AccessGUDID - DEVICE: CardioWrap® (08964050362025)

GUDID

Device Identifier (DI) Information

Brand Name: CardioWrap®
Version or Model: 100 x 130 x 0.02mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 36202-01
Company Name: MAST BIOSURGERY USA INC.

Primary DI Number: 08964050362025
Issuing Agency: GS1
Commercial Distribution End Date: November 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 188582360 *Terms of Use

Device Description: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

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?
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An implantable material (e.g., flat sheet) made from a 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]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OMH	Pericardial Patch To Facilitate Revision Surgeries

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031785	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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 130 Millimeter
Width: 100 Millimeter
Device Size Text, specify: Thickness: 0.02 Millimeter

Device Record Status

Public Device Record Key: acdbd270-5be8-4df8-a8e8-4059a2b6371d
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: October 23, 2015