Identity
- Trade Name
- ExoShape FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- ACL Procedure Pack, Sterile FDA UDI
- Model / Reference
- 1101-02-000 FDA UDI
- Description
- ACL Procedure Pack, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9701101020000 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone wireSuturing unit, single-useSkin marking pen, single-useLigament graft sizer, noninvasive
ExoShape by Medshape, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medshape, Inc.
Sources (1)
- FDA UDI 1fe9d257-c97c-484f-949a-d0db056bdd28 33 fields · synced Jun 8, 2026