Identity
- Trade Name
- Speedlock FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Biopsy Spoon, 5mm, Double Action with Ratchet Handle: 8510-01 Composite Reinforced Safety, 30cm Length FDA UDI
- Model / Reference
- 8517-08-30-R/8510-01 FDA UDI
- Description
- Biopsy Spoon, 5mm, Double Action with Ratchet Handle: 8510-01 Composite Reinforced Safety, 30cm Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657064804 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, reusable
Speedlock is a rigid, hand-held manual surgical instrument designed for grasping and manipulating tissues during endoscopic surgery. This reusable device has distal grasping jaws and proximal controls, making it an ideal tool 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
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 53540faf-dd47-4c4d-a74d-404b016bfcd1 33 fields · synced Jul 13, 2026