Identity
- Trade Name
- Speedlock FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Speedlock Mixter Clamp, 10mm, 45 Degree Angled, 10mm, with Ratchet Handle: D1368 Composite On/Off Ratchet, 45cm Length FDA UDI
- Model / Reference
- 8514-33-45-R/D1368 FDA UDI
- Description
- Speedlock Mixter Clamp, 10mm, 45 Degree Angled, 10mm, with Ratchet Handle: D1368 Composite On/Off Ratchet, 45cm Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657050562 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Rigid endoscopic tissue manipulation forceps, reusable
A medical device designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) for grasping and manipulating tissues during endoscopic surgery. It features a rigid, hand-held manual surgical instrument with proximal controls, a rigid long slender shaft, and distal grasping jaws.
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
- HYSAFE — Richard Wolf GmbH · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- CLICKLINE — Karl Storz GmbH & Co. KG · Class II
- Endoplus — Endoplus · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- ReNew — MICROLINE SURGICAL, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI bb616d38-43e9-4589-b240-159c77f771d1 33 fields · synced Jul 25, 2026