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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Fibreoptic retractor handle FDA UDI
Device Name
AUFRICHT NASAL RETRACTOR WITH LIGHT GUIDE & SUCTION, 7X45MM BLADE SIZE, 7” (18CM) FDA UDI
Model / Reference
37-1008 FDA UDI
Description
AUFRICHT NASAL RETRACTOR WITH LIGHT GUIDE & SUCTION, 7X45MM BLADE SIZE, 7” (18CM) FDA UDI

Identifiers

Catalog Number
37-1008 FDA UDI
Primary DI / UDI-DI
00198506056963 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Fibreoptic retractor handle 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fibreoptic retractor handle

Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fibreoptic retractor handle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 2c1323aa-83ed-4631-b516-7ae81dc687bd 35 fields · synced Jun 8, 2026