← Back to catalogue

Müller introducer

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name
Müller introducer FDA UDI
Generic Name
Cochlear electrode array introducer, reusable FDA UDI
Device Name
for cochlea implants, straight golden handle, 18 cm FDA UDI
Model / Reference
10-660-00 FDA UDI
Description
for cochlea implants, straight golden handle, 18 cm FDA UDI

Identifiers

Catalog Number
10-660-00 FDA UDI
Primary DI / UDI-DI
04250381849545 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Cochlear electrode array introducer, 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: Cochlear electrode array introducer, reusable

Müller introducer by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cochlear electrode array introducer, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spiggle & Theis Medizintechnik GmbH

Sources (1)

  • FDA UDI 78ff6030-1487-4685-92fe-fd2470baf1c4 35 fields · synced May 30, 2026