AccessGUDID - DEVICE: AMS 700 (00878953003054)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 700
Version or Model: 72404123
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AMERICAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00878953003054
Issuing Agency: GS1
Commercial Distribution End Date: January 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 125111448 *Terms of Use

Device Description: IPP Surgical Tool System 1 AMS Connector Tool 1 AMS Insertion Package 1 AMS Furlow Cylinder Inserter 1 Proximal Tool (Sterile)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
32864	Wire/ligature passer, reusable	A hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCW	Prosthesis, Penis, Inflatable

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 3e0a783c-0cf7-4662-a1ae-1d25223b551e
Public Version Date: February 13, 2019
Public Version Number: 6
DI Record Publish Date: September 25, 2014