AccessGUDID - DEVICE: Proximal Tool (00878953003023)

GUDID

Device Identifier (DI) Information

Brand Name: Proximal Tool
Version or Model: 72404120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AMERICAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00878953003023
Issuing Agency: GS1
Commercial Distribution End Date: December 11, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 125111448 *Terms of Use

Device Description: Proximal Cylinder Insertion 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:	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?
60798	Penile prosthesis implantation instrument	A sterile, hand-held manual surgical instrument intended to be used to implant a penile prosthesis (e.g., penile prosthesis cylinder insertion within the corpora cavernosa). It may also be used during revision surgery of a penile prosthesis; it has no general surgical application. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCW	Prosthesis, Penis, Inflatable
FHW	Device, Impotence, Mechanical/Hydraulic

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: Yes
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: f89095f0-d9c6-4ec9-8f04-5853193025be
Public Version Date: January 28, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2014