Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Craniofacial bone screw, bioabsorbable FDA UDI
- Device Name
- 1.6mm x 4mm Resorbable Screw, 10 Pack FDA UDI
- Model / Reference
- 250-1604-SP FDA UDI
- Description
- 1.6mm x 4mm Resorbable Screw, 10 Pack FDA UDI
Identifiers
- Catalog Number
- 250-1604-SP FDA UDI
- Primary DI / UDI-DI
- 00845694007900 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial bone screw, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 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
Dimensions & Sizes
- Size
- Length — 4 Millimeter FDA UDI
Category: Craniofacial bone screw, bioabsorbable
OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, bioabsorbable.
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- DELTA — Stryker Leibinger · Class II
- DELTA — Stryker Leibinger · Class II
- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC · Class II
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC · Class II
- RESORB X, STERILE — KLS-Martin L.P. · Class II
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
- Osteomed Corp.
Sources (1)
- FDA UDI 4e61843e-9a51-417b-a91b-b24d173677e4 37 fields · synced Jun 8, 2026