Identity
- Trade Name
- ExpressBraid™ Graft Manipulation FDA UDI
- Generic Name
- Operative-site suture holder FDA UDI
- Model / Reference
- 110003540 FDA UDI
Identifiers
- Catalog Number
- 110003540 FDA UDI
- Primary DI / UDI-DI
- 00887868462689 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Operative-site suture holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Operative-site suture holder
ExpressBraid™ Graft Manipulation by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152868 also covers:
- EXPRESSBRAID — Biomet Orthopedics, Inc.
- EXPRESSBRAID — Biomet Orthopedics, Inc.
- EXPRESSBRAID GRAFT MANIPULATION — Biomet Orthopedics, Inc.
- EXPRESSBRAID GRAFT MANIPULATION — Biomet Orthopedics, Inc.
- ExpressBraid™ — Biomet Orthopedics, Inc.
- ExpressBraid™ Graft Manipulation — Biomet Orthopedics, Inc.
- ExpressBraid™ Graft Manipulation — Biomet Orthopedics, Inc.
K163651 also covers:
- EXPRESSBRAID — Biomet Orthopedics, Inc.
- EXPRESSBRAID — Biomet Orthopedics, Inc.
- EXPRESSBRAID GRAFT MANIPULATION — Biomet Orthopedics, Inc.
- EXPRESSBRAID GRAFT MANIPULATION — Biomet Orthopedics, Inc.
- ExpressBraid™ — Biomet Orthopedics, Inc.
- ExpressBraid™ Graft Manipulation — Biomet Orthopedics, Inc.
- ExpressBraid™ Graft Manipulation — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 7e76e063-8fb0-4726-acc9-8ce439a8a433 36 fields · synced Jun 8, 2026