Identity
- Trade Name
- APTUS FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- 2.0 K-Wire, 75mm, Olive 25mm, No Thread FDA UDI
- Model / Reference
- A-5046.64/2S FDA UDI
- Description
- 2.0 K-Wire, 75mm, Olive 25mm, No Thread FDA UDI
Identifiers
- Catalog Number
- A-5046.64/2S FDA UDI
- Primary DI / UDI-DI
- 07630894810978 FDA UDI
- FDA Product Code
- GDF FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
Aptus by Medartis Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- TMC PSI Cut Guide System — TREACE MEDICAL CONCEPTS, INC. · Class I
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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
- Medartis Inc.
Sources (1)
- FDA UDI 3671ad16-0de1-4e4d-a656-e373e7e6e316 34 fields · synced May 30, 2026