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Acra-Cut AcraClip Disposable Scalp Clips - HSA Registration DE0508373

Access comprehensive regulatory information for Acra-Cut AcraClip Disposable Scalp Clips in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508373 and owned by Acra-Cut Inc.. The device was registered on August 14, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0508373
Acra-Cut AcraClip Disposable Scalp Clips
HSA Registration Number: DE0508373
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Product Description

ACRACLIPS are disposable scalp clips designed for use with the reusable ACRAGUN (Model 500-100). ACRACLIPS are for hemostasis of the scalp flap edges during cranial surgery.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0508373
Registration Date
August 14, 2023
Retention Due Date
August 13, 2025
Product Owner
Short Name
Acra-Cut
Address
989 Main Street, Acton, Massachusetts, 01720, UNITED STATES
Registrant
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model Information
Model Name(s)
Reusable Acragun with sterilizing case Straight Edge, Heavy Force, Adult Scalp, two 15-clip cartridges Serrated Edge, Light Force, Pediatric Scalp, two 15-clip cartridges Serrated Edge, Medium Force, Adult Scalp, two 15-clip cartridges Serrated Edge, Heavy Force, Adult Scalp, two 15-clip cartridges Straight Edge, Medium Force, Adult Scalp, one 15-clip cartridge Straight Edge, Heavy Force, Adult Scalp, one 15-clip cartridge Serrated Edge, Light Force, Pediatric Scalp, one 15-clip cartridge Serrated Edge, Medium Force, Adult Scalp, one 15-clip cartridge Serrated Edge, Heavy Force, Adult Scalp, one 15-clip cartridge Reusable Acra-Cut Clip Applier/ Remover
Model Identifier(s)
500-100 500-103 500-104 500-105 500-106 500-108 500-109 500-110 500-111 500-112 500-135