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Speedlock

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name
Speedlock FDA UDI
Generic Name
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Device Name
Babcock, Short Version for Delicate Applications, 5mm Handle: 1358 Axial Thumb Release, 45cm Length FDA UDI
Model / Reference
8515-09-45/1358 FDA UDI
Description
Babcock, Short Version for Delicate Applications, 5mm Handle: 1358 Axial Thumb Release, 45cm Length FDA UDI

Identifiers

Primary DI / UDI-DI
00848657057509 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscopic tissue manipulation forceps, reusable

Speedlock by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid endoscopic tissue manipulation forceps, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
National Advanced Endoscopy Devices, Inc.

Sources (1)

  • FDA UDI 9ba7585a-1607-40c7-b8d1-228048e5275c 33 fields · synced Jun 8, 2026