Identity
- Trade Name
- Safedge FDA UDI
- Generic Name
- Sternum saw blade, single-use FDA UDI
- Device Name
- Safedge 2108 Series Sagittal Blade Sternum Revision (40.3 x 0.64 x 48.4mm) FDA UDI
- Model / Reference
- 2108125000 FDA UDI
- Description
- Safedge 2108 Series Sagittal Blade Sternum Revision (40.3 x 0.64 x 48.4mm) FDA UDI
Identifiers
- Catalog Number
- 2108-125-000 FDA UDI
- Primary DI / UDI-DI
- 04546540042088 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Sternum saw blade, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
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
- Depth — 48.4 Millimeter FDA UDI
Category: Sternum saw blade, single-use
Safedge by Stryker Corp. — 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
- Stryker Corp.
Sources (1)
- FDA UDI 6f8a0dca-f322-4730-b7e4-d7a7aeaf7b5b 36 fields · synced Jun 6, 2026