AccessGUDID - DEVICE: AMS 700 LGX™ TENACIO™ Pump (00191506021252)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 700 LGX™ TENACIO™ Pump
Version or Model: 72404405
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72404405
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00191506021252
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, Preconnected-Infrapubic

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?
36250	Inflatable penile prosthesis	An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.	Active	true

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
Length: 12 Centimeter

Device Record Status

Public Device Record Key: 0908479d-de4f-4042-a398-dcc28f6c4e86
Public Version Date: February 05, 2024
Public Version Number: 1
DI Record Publish Date: January 26, 2024