Identity
- Trade Name
- Stryker FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Palatal Retractor EUDAMED4 Degree Cobb, 22mm FDA UDI
- Model / Reference
- 48970007 EUDAMEDFDA UDI
- Description
- 4 Degree Cobb, 22mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776140472 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776RETRACT2N EUDAMED
- Direct Marketing DI
- 00190776140472 EUDAMED
- FDA Product Code
- GEG FDA UDI
- EMDN Code
- L0902 ORTHOPAEDIC SURGERY LEVERS, REUSABLE EUDAMED
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone lever/elevator, reusable
Stryker by AVALIGN TECHNOLOGIES, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone lever/elevator, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class I
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
- ORTHOMED — ORTHO-MED, INC. · Class I
- Symmetry Allerdyce — SYMMETRY SURGICAL INC. · Class I
- Life Instruments — Life Instrument Corporation · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (2)
- FDA UDI ab5fe353-caa4-45ac-8844-12d37130ff7e 34 fields · synced Jun 19, 2026
- EUDAMED 94a801c1-7d8a-45c7-9a4b-b90f92b7851c 61 fields · synced Jun 19, 2026