Identity
- Trade Name
- Speedlock FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Atraumatic Grasper, 5mm, Diamond Serrations with Ratchet Handle: 8511-01 Standard Composite, 45cm Length FDA UDI
- Model / Reference
- 8510-46-45-R/8511-01 FDA UDI
- Description
- Atraumatic Grasper, 5mm, Diamond Serrations with Ratchet Handle: 8511-01 Standard Composite, 45cm Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657028820 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
Speedlock, a rigid, hand-held manual surgical instrument designed for grasping and manipulating tissues during endoscopic surgery. Featuring proximal controls (e.g., scissors-like handles), a long slender shaft with distal grasping jaws, Speedlock is not an electrosurgical device or dedicated to biopsy. It's a reusable tool suitable for various medical procedures.
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
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- 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 6b5d6991-d711-4a3a-94b0-19142b68a4c6 33 fields · synced Jul 29, 2026