Identity
- Trade Name
- Stryker FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- PHANTOM ML RETRACTOR BLADES (L&R), 18MM DIA. X 120MM, PURPLE SPLASH FDA UDI
- Model / Reference
- 48251812 FDA UDI
- Description
- PHANTOM ML RETRACTOR BLADES (L&R), 18MM DIA. X 120MM, PURPLE SPLASH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059100839 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Stryker by Tedan Surgical Innovations, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI aaec1b28-d9a8-4b65-ba2c-e0aa03a6dba6 34 fields · synced Jun 8, 2026