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Histolock

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name
Histolock FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting, and collecting flat lesions. The kit is made up of the Histolock Resection Device, Carr-Locke injection needle, eTrap polyp trap and Mio medical device organizer. FDA UDI
Model / Reference
00711873 FDA UDI
Description
The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting, and collecting flat lesions. The kit is made up of the Histolock Resection Device, Carr-Locke injection needle, eTrap polyp trap and Mio medical device organizer. FDA UDI

Identifiers

Catalog Number
00711873 FDA UDI
Primary DI / UDI-DI
00816765012840 FDA UDI
FDA Product Code
FCG FDA UDI
FDI FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
876.4300 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Histolock by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI 16ae9a47-ed94-4b21-9a6d-e0c771fdbf22 37 fields · synced Jun 1, 2026