Gimmi

FDA UDI

Class II (US FDA UDI)

by Gimmi GmbH

Identity

Trade Name: Gimmi FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: "OFFICE" OUTER SHEATH FOR CONTINUOUS FLOW, 1 RIGID STOPCOCK, Ø 5,1 MM FOR SHEATH T.8031.80, W.-L. 21,5 CM FDA UDI
Model / Reference: T.8031.82 I FDA UDI
Description: "OFFICE" OUTER SHEATH FOR CONTINUOUS FLOW, 1 RIGID STOPCOCK, Ø 5,1 MM FOR SHEATH T.8031.80, W.-L. 21,5 CM FDA UDI

Identifiers

Catalog Number: T.8031.82 I FDA UDI
Primary DI / UDI-DI: 04049047632795 FDA UDI
FDA Product Code: HIH FDA UDI
GMDN Term: Endoscope sheath, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscope sheath, reusable

Gimmi by Gimmi GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Gimmi GmbH

Sources (1)

FDA UDI 42558539-5529-4468-852b-60a38925ef9e 35 fields · synced May 30, 2026