AccessGUDID - DEVICE: Male Remeex System - Thread Passer (08436568350899)

GUDID

Device Identifier (DI) Information

Brand Name: Male Remeex System - Thread Passer
Version or Model: AR-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL

Primary DI Number: 08436568350899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 513271056 *Terms of Use

Device Description: No description.

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):	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?
47441	Transvaginal mesh-sling introduction needle	A hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a mesh-sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse. The distal working end is typically made of a high-grade stainless steel curved rod with a pointed tip and an eye or notch to help position the mesh-sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 0998e3c3-3787-4a36-87d5-003fe156e3da
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: October 19, 2020