AccessGUDID - DEVICE: REMA Endo Retractors (04059223112447)

GUDID

Device Identifier (DI) Information

Brand Name: REMA Endo Retractors
Version or Model: 29-033-760
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DEWIMED Medizintechnik GmbH

Primary DI Number: 04059223112447
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343472288 *Terms of Use

Device Description: Oesophageal retractor for gastric banding 10mm x 430mm with hole for thread at the tip of the mouth

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65538	Hand-held endoscopic retractor, reusable	A hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDG	Hook, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Shaft Length: 430 Millimeter

Device Record Status

Public Device Record Key: b12a44f1-bdf0-4f63-8e65-1bebab10e7b4
Public Version Date: November 25, 2024
Public Version Number: 1
DI Record Publish Date: November 15, 2024