AccessGUDID - DEVICE: Rear Tip Extender (00878953004112)

GUDID

Device Identifier (DI) Information

Brand Name: Rear Tip Extender
Version or Model: 72404330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72404330
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953004112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Stackable Rear Tip Extender for AMS 700 Inflatable Penile Prosthesis CX and LGX Cylinders

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
60781	Penile prosthesis extender	A sterile implantable device intended to extend the cylinder component of a penile prosthesis to achieve an overall cylinder length which fits the measurements of the patient's anatomy (i.e., corpora cavernosa length). It is a synthetic polymer (e.g., silicone) moulded cap available in a variety of sizes and is intended to be attached to the end of a penile prosthesis cylinder during implantation, in cases where the cylinder is of insufficient length.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JCW	Prosthesis, Penis, Inflatable
FAE	Prosthesis, Penile

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
Length: 1.5 Centimeter

Device Record Status

Public Device Record Key: 59bd955c-b1d4-41fe-9081-2cf53f6249a1
Public Version Date: September 16, 2024
Public Version Number: 6
DI Record Publish Date: August 12, 2016