AccessGUDID - DEVICE: Rectosigmoidoscope with Obturator (05704916001353)

GUDID

Device Identifier (DI) Information

Brand Name: Rectosigmoidoscope with Obturator
Version or Model: UA0672
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bk Medical ApS

Primary DI Number: 05704916001353
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 310093901 *Terms of Use

Device Description: Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052

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?
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173569	000
K180737	000
K223830	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 616b2a4c-8d0d-44bb-a61f-427bdbdbf258
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025