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PSD gel

FDA UDI

Class II (US FDA UDI)

by Synovis Life Technologies, Inc.

Identity

Trade Name
PSD gel FDA UDI
Generic Name
Staple line-reinforcement strip gel FDA UDI
Device Name
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. FDA UDI
Model / Reference
PSDGEL3PKWTIPS FDA UDI
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. FDA UDI

Identifiers

Catalog Number
PSDGel3pkwTips FDA UDI
Primary DI / UDI-DI
00085412531434 FDA UDI
FDA Product Code
FTM FDA UDI
GMDN Term
Staple line-reinforcement strip gel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Staple line-reinforcement strip gel

PSD gel by Synovis Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI a8cecb0e-4f69-43d8-901f-c5a34c7cd245 36 fields · synced May 30, 2026