AccessGUDID - DEVICE: m-protect3 (04262358420022)

GUDID

Device Identifier (DI) Information

Brand Name: m-protect3
Version or Model: 28/29
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MP0028/29
Company Name: qtec CE-med GmbH

Primary DI Number: 04262358420022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344010844 *Terms of Use

Device Description: m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis.

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):	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?
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	Surgical Instruments, G-U, Manual (And Accessories)

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: keep dry, keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: suitable for stapler size 28/29

Device Record Status

Public Device Record Key: 8ac673cc-4032-401b-ad1b-f9cc198d3783
Public Version Date: April 04, 2025
Public Version Number: 2
DI Record Publish Date: July 17, 2023