AccessGUDID - DEVICE: AMS Ambicor (00878953001012)

GUDID

Device Identifier (DI) Information

Brand Name: AMS Ambicor
Version or Model: 72401457
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72401457
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953001012
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

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?
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
FHW	Device, Impotence, Mechanical/Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
N970012	000
N970012	094
N970012	096
N970012	110
N970012	118
N970012	121
N970012	145
N970012	151
N970012	157
N970012	158
N970012	161

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: 15.5 Millimeter
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 2c81ee0c-a126-4e91-8c81-3c3bd81dba3c
Public Version Date: October 22, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2014