AccessGUDID - DEVICE: AMS 700™ with TENACIO™ Pump Accessory Kit (00191506021696)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 700™ with TENACIO™ Pump Accessory Kit
Version or Model: 72404850
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72404850
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506021696
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Inflatable Penile Prosthesis Accessory Kit

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:	Yes
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?
60787	Penile prosthesis implantation kit	A collection of manual surgical instruments intended to be used during implantation of a penile prosthesis [for the treatment of erectile dysfunction (ED)]. The kit typically contains tools associated with insertion, measurement, and/or assembly of the implant; it does not contain any pharmaceuticals. This is a reusable device intended to be sterilized prior to use; it may contain disposable items that need to be replenished before reuse.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCW	Prosthesis, penis, inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
N970012	197

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: dd8d1d3d-f1cb-4753-8751-14317903ec0f
Public Version Date: February 05, 2024
Public Version Number: 1
DI Record Publish Date: January 26, 2024