Identity
- Trade Name
- Speedlock FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Tumor Grasper, 5mm, Blunt End Handle: 1358 Axial Thumb Release, 34cm Length FDA UDI
- Model / Reference
- 8510-03/1358 FDA UDI
- Description
- Tumor Grasper, 5mm, Blunt End Handle: 1358 Axial Thumb Release, 34cm Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657023634 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 is a reusable, rigid endoscopic tissue manipulation forceps designed for grasping and manipulating tissues during endoscopic surgery. With its proximal controls, flexible long slender shaft, and distal grasping jaws, it's ideal for various medical procedures. This device has been in commercial distribution since 2016 and is not an electrosurgical device or dedicated to biopsy. It's compatible with both moist heat and steam sterilization methods.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 2885aba6-dbfa-4f6f-afcc-956df45007d1 33 fields · synced Jul 2, 2026