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Endo-Boot

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name
Endo-Boot FDA UDI
Generic Name
Surgical instrument guard, single-use, sterile FDA UDI
Device Name
The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport. FDA UDI
Model / Reference
00711622 FDA UDI
Description
The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport. FDA UDI

Identifiers

Catalog Number
00711622 FDA UDI
Primary DI / UDI-DI
10724995184022 FDA UDI
FDA Product Code
OCU FDA UDI
GMDN Term
Surgical instrument guard, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Category: Surgical instrument guard, single-use, sterile

Endo-Boot by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument guard, single-use, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI e75526ad-518d-4c4c-8b69-1e6bf610de22 36 fields · synced Jun 6, 2026