AccessGUDID - DEVICE: Supple Peri-Guard (00085412530642)

GUDID

Device Identifier (DI) Information

Brand Name: Supple Peri-Guard
Version or Model: PC0404SN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC0404SNBIO
Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.

Primary DI Number: 00085412530642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017415781 *Terms of Use

Device Description: SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.

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?
35273	Cardiovascular patch, animal-derived	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, surgical
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
OWV	Mesh, surgical, collagen, diaphragmatic hernia
OXB	Mesh, surgical, collagen, thoracic, chest wall reconstruction

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: Do not freeze
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b27cc05-48d8-483c-9d1d-aacfa3d3c900
Public Version Date: October 31, 2023
Public Version Number: 7
DI Record Publish Date: October 08, 2015