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Laser-Vocal cord spreader

FDA UDI

Class I (US FDA UDI)

by Spiggle & Theis Medizintechnik GmbH

Identity

Trade Name
Laser-Vocal cord spreader FDA UDI
Generic Name
Over-guidewire oesophageal dilator FDA UDI
Device Name
cylindrical shaft, with ratchet irrigation channel, 2.0 mm, 26.5 cm FDA UDI
Model / Reference
50-652-23-L FDA UDI
Description
cylindrical shaft, with ratchet irrigation channel, 2.0 mm, 26.5 cm FDA UDI

Identifiers

Catalog Number
50-652-23-L FDA UDI
Primary DI / UDI-DI
04250676742797 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Over-guidewire oesophageal dilator 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: Over-guidewire oesophageal dilator

Laser-Vocal cord spreader by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Over-guidewire oesophageal dilator.

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 b411f848-19c8-4d98-8cb2-f0cf90cea211 35 fields · synced May 30, 2026