AccessGUDID - DEVICE: PROLITE ULTRA (00650862308044)

GUDID

Device Identifier (DI) Information

Brand Name: PROLITE ULTRA
Version or Model: 30804
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Atrium Medical Corporation

Primary DI Number: 00650862308044
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 051798999 *Terms of Use

Device Description: ProLite Ultra, SFP SMALL KEYHOLE, 1.0in. x 2in. (2.5cm x 5cm), 3.5in. (8.9cm)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60300	Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable	An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, surgical, polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002093	000
K151437	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 57ad3fe4-52b8-47e2-9fde-63b55c2ccae8
Public Version Date: June 10, 2022
Public Version Number: 8
DI Record Publish Date: September 24, 2015