AccessGUDID - DEVICE: Rectoscope equipment (08033638800713)

GUDID

Device Identifier (DI) Information

Brand Name: Rectoscope equipment
Version or Model: Rectoscope equipment with LED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A.4525LINS
Company Name: SAPI MED SPA

Primary DI Number: 08033638800713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 437320088 *Terms of Use

Device Description: Non sterile and disposable equipment made of 250mm rectoscope, grip, insufflator and built-in LED light.

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:	Yes
Prescription Use (Rx):	No
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?
40502	Optical proctoscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDM	Sigmoidoscope, Rigid, Non-Electrical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070915	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: 407f8cfe-541c-4ae9-b2be-2b38f5339040
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: July 27, 2023