Identity
- Trade Name
- GYRUS ACMI, INC FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- SCHUKNECHT WIRE PISTON .8 MM DIAMETER 4.5 MM LENGTH FLUOROPLASTIC-STAINLESS FDA UDI
- Model / Reference
- 140106 FDA UDI
- Description
- SCHUKNECHT WIRE PISTON .8 MM DIAMETER 4.5 MM LENGTH FLUOROPLASTIC-STAINLESS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925017184 FDA UDI
- 510(k) Number
- K760433 FDA UDI
- FDA Product Code
- ETA FDA UDI
- GMDN Term
- Polyethylene craniofacial tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3495 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyethylene craniofacial tissue reconstructive material
Gyrus Acmi, Inc by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K760433 also covers:
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 88580c49-fbe7-4dce-b08b-b18be15247f5 35 fields · synced May 31, 2026