AccessGUDID - DEVICE: Quick Connect Assembly Tool (00878953000831)

GUDID

Device Identifier (DI) Information

Brand Name: Quick Connect Assembly Tool
Version or Model: 72400271
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72400271
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953000831
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Connector Assembly Tool

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?
66783	Urological prosthesis tubing connection crimper	A hand-held manual surgical instrument intended to connect the tubing ends of an implanted urological prosthesis (e.g., inflatable penile prosthesis, urethral sphincter prosthesis) to a connector through compression (crimping). It has a pliers-like design with handles and jaws; the prosthesis is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGA	Penile implant surgical accessories
QGD	Implanted mechanical/hydraulic urinary continence device surgical 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: 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: 071aa415-5f3e-48fc-ba8b-524a2732933a
Public Version Date: November 04, 2024
Public Version Number: 9
DI Record Publish Date: September 24, 2014