Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 5MM DIA., 24CM, BULLET-NOSE GRASPER/DISSECTOR, TC MICRO-DIAMOND JAW PATTERN W/ 22MM SINGLE-ACTION, INSULATED SHAFT & HANDLE W/ RF-POST, MODULAR 3-PIECE SCREW-APART FDA UDI
- Model / Reference
- 52224-80C FDA UDI
- Description
- 5MM DIA., 24CM, BULLET-NOSE GRASPER/DISSECTOR, TC MICRO-DIAMOND JAW PATTERN W/ 22MM SINGLE-ACTION, INSULATED SHAFT & HANDLE W/ RF-POST, MODULAR 3-PIECE SCREW-APART FDA UDI
Identifiers
- Catalog Number
- 52224-80C FDA UDI
- Primary DI / UDI-DI
- 00842180132474 FDA UDI
- FDA Product Code
- GCJ FDA UDIGEI FDA UDI
- GMDN Term
- Laparoscopic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4400 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: Laparoscopic surgical procedure kit, non-medicated, reusable
Elmed by Elmed Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic surgical procedure kit, non-medicated, reusable.
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI bedbb24d-9b1e-4747-9dd5-3312e910c2a9 35 fields · synced May 31, 2026