AccessGUDID - DEVICE: PSD gel (00085412531434)

GUDID

Device Identifier (DI) Information

Brand Name: PSD gel
Version or Model: PSDGEL3PKWTIPS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSDGel3pkwTips
Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.

Primary DI Number: 00085412531434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017415781 *Terms of Use

Device Description: PSD Gel is prepared from Hydroxypropyl Methyl Cellulose, Propylene Glycol, and water. The PSD Gel is used to bond the Peri-Strips Dry pericardium strips onto the surgical stapler forks until the stapler is positioned and fired.

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?
58268	Staple line-reinforcement strip gel	A sterile gelatinous substance designed to be used during staple line buttress (reinforcement) procedures (e.g., lung/bronchus resections, bariatric and small bowel surgery). It is typically applied to the buttress strip material to facilitate rehydration and temporary adherence to the surgical stapler unit prior to the application of the staples and buttress strip to body tissue. It typically consists of a colloidal suspension (hydrogel) applied with an included applicator. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, surgical

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
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: a8cecb0e-4f69-43d8-901f-c5a34c7cd245
Public Version Date: October 30, 2023
Public Version Number: 5
DI Record Publish Date: October 05, 2015