Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- "Cooley Cosgrove Mitral Valve Heart Retractor Complete Set Includes the below: (1) Cooley Rib Spreader Adult Blades 40* 110mm With Cosgrove mounting Bars (1) Main Bracket Attachment (3) Universal Clamps (1) Side Arm Bar (1) Tricuspid Retractor Blade (1) Large Retractor Blade (3) Small Retractor Blades" FDA UDI
- Model / Reference
- ST248100 FDA UDI
- Description
- "Cooley Cosgrove Mitral Valve Heart Retractor Complete Set Includes the below: (1) Cooley Rib Spreader Adult Blades 40* 110mm With Cosgrove mounting Bars (1) Main Bracket Attachment (3) Universal Clamps (1) Side Arm Bar (1) Tricuspid Retractor Blade (1) Large Retractor Blade (3) Small Retractor Blades" FDA UDI
Identifiers
- Catalog Number
- ST248100 FDA UDI
- Primary DI / UDI-DI
- 00842180199149 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retraction system, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retraction system, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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
- Elmed Incorporated
Sources (1)
- FDA UDI 35a5406d-20d7-46e2-b92a-e076235f535f 35 fields · synced May 31, 2026