AccessGUDID - DEVICE: Elevate (00814723020050)

GUDID

Device Identifier (DI) Information

Brand Name: Elevate
Version or Model: 720093-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 720093-01
Company Name: ENDO PHARMACEUTICALS INC.

Primary DI Number: 00814723020050
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 178074951 *Terms of Use

Device Description: Elevate Anterior & Apical

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:	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?
60842	Pelvic organ prolapse surgical mesh, synthetic polymer	A sterile woven/knitted or porous material comprised of a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OTP	Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store product in a clean, dry, dark area at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc34f926-5e45-4765-b894-4877471ab529
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 24, 2015