REMA Endo Retractors

FDA UDI

Class I (US FDA UDI)

by DEWIMED Medizintechnik GmbH

Identity

Trade Name: REMA Endo Retractors FDA UDI
Generic Name: Hand-held endoscopic retractor, reusable FDA UDI
Device Name: Oesophageal retractor for gastric banding 10mm x 430mm with hole for thread at the tip of the mouth FDA UDI
Model / Reference: 29-033-760 FDA UDI
Description: Oesophageal retractor for gastric banding 10mm x 430mm with hole for thread at the tip of the mouth FDA UDI

Identifiers

Primary DI / UDI-DI: 04059223112447 FDA UDI
FDA Product Code: GDG FDA UDI
GMDN Term: Hand-held endoscopic retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Dimensions & Sizes

Size: Outer Diameter — 10 Millimeter FDA UDI
Shaft Length — 430 Millimeter FDA UDI

Category: Hand-held endoscopic retractor, reusable

REMA Endo Retractors by DEWIMED Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held endoscopic retractor, reusable.

Snowden-Pencer — STERIS CORPORATION · Class II
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Symmetry Lowsley — SYMMETRY SURGICAL INC. · Class I
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
Snowden-Pencer — STERIS CORPORATION · Class II
BOSS Instruments — Boss Instruments, Ltd. · Class I

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

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

Manufacturer

Manufacturer: DEWIMED Medizintechnik GmbH

Sources (1)

FDA UDI b12a44f1-bdf0-4f63-8e65-1bebab10e7b4 34 fields · synced Jun 8, 2026