AccessGUDID - DEVICE: AMS 700 LGX MS Pump (00878953009827)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 700 LGX MS Pump
Version or Model: 72404253-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72404253-12
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953009827
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, Preconnect Penoscrotal, 1 Pump to 2 Cylinders with 12 cm long preconnect tubing , InhibiZone treated

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:	Yes
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	139
N970012	145
N970012	150
N970012	161
N970012	163
N970012	177
N970012	196

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
Outer Diameter: 12 Millimeter
Length: 21 Centimeter

Device Record Status

Public Device Record Key: 505c6137-773c-4ee5-82ef-f08030e1ae70
Public Version Date: March 24, 2025
Public Version Number: 13
DI Record Publish Date: January 26, 2018