Silicone tubing, slit

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name: Silicone tubing, slit FDA UDI
Generic Name: Surgical instrument guard, reusable FDA UDI
Device Name: for frame of McIvor mouth gag re-useable, 5 pieces FDA UDI
Model / Reference: 40-305-99 FDA UDI
Description: for frame of McIvor mouth gag re-useable, 5 pieces FDA UDI

Identifiers

Catalog Number: 40-305-99 FDA UDI
Primary DI / UDI-DI: 04250381893555 FDA UDI
FDA Product Code: LRC FDA UDI
GMDN Term: Surgical instrument guard, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument guard, reusable

Silicone tubing, slit by Spiggle & Theis Medizintechnik GmbH — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Spiggle & Theis Medizintechnik GmbH

Sources (1)

FDA UDI 2d5e5c85-53fc-425c-9fc2-1f980e4a441f 35 fields · synced May 29, 2026