AccessGUDID - DEVICE: PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP (00085412658803)

GUDID

Device Identifier (DI) Information

Brand Name: PERI-STRIPS DRY WITH VERITASWITH SECURE GRIP
Version or Model: PSDA60ECH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSDA60ECH
Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.

Primary DI Number: 00085412658803
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017415781 *Terms of Use

Device Description: PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG 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?
47818	Staple line-reinforcement strip	A sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OXE	Mesh, surgical, collagen, staple line reinforcement
FTM	Mesh, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192615	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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Millimeter

Device Record Status

Public Device Record Key: 845da1bd-ddb0-4d13-9160-3588dbc9810a
Public Version Date: August 25, 2023
Public Version Number: 5
DI Record Publish Date: February 10, 2020