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T-tube inserter, dismountable

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name
T-tube inserter, dismountable FDA UDI
Generic Name
Tympanostomy tube inserter, reusable FDA UDI
Device Name
for t-tubes with 6, 9 and 12 mm FDA UDI
Model / Reference
10-760-00 FDA UDI
Description
for t-tubes with 6, 9 and 12 mm FDA UDI

Identifiers

Catalog Number
10-760-00 FDA UDI
Primary DI / UDI-DI
04250381850015 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Tympanostomy tube inserter, 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Tympanostomy tube inserter, reusable

T-tube inserter, dismountable by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tympanostomy tube inserter, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spiggle & Theis Medizintechnik GmbH

Sources (1)

  • FDA UDI 17f7d780-249f-47e1-93f9-af7c7f0e3127 35 fields · synced Jun 8, 2026