Identity
- Trade Name
- MEGA PLUS SPINE SYSTEM FDA UDI
- Generic Name
- Surgical flat-nosed pliers FDA UDI
- Device Name
- Rod Gripper FDA UDI
- Model / Reference
- 51740 FDA UDI
- Description
- Rod Gripper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809763500152 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical flat-nosed pliers FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical flat-nosed pliers
Mega Plus Spine System by Bk Meditech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical flat-nosed pliers.
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- STILLE Pliers — Stille AB · Class I
- FORCEPS — KLS-Martin L.P. · Class I
- STOMA® — Storz am Mark GmbH · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · 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
- Bk Meditech Co., Ltd.
Sources (1)
- FDA UDI 513f87aa-59dc-410b-9d9d-34b713c0d684 33 fields · synced Jun 8, 2026