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Syvek Patch

FDA UDI

Class I (US FDA UDI)

by Marine Polymer Technologies, Inc.

Identity

Trade Name
Syvek Patch FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
Device Name
Syvek is a 3 cm x 3 cm patch used for vascular hemostasis FDA UDI
Model / Reference
400-02 FDA UDI
Description
Syvek is a 3 cm x 3 cm patch used for vascular hemostasis FDA UDI

Identifiers

Primary DI / UDI-DI
00389142000087 FDA UDI
510(k) Number
K984177 FDA UDI
FDA Product Code
KMF FDA UDI
GMDN Term
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5090 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Category: Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

Syvek Patch by Marine Polymer Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Marine Polymer Technologies, Inc.

Sources (1)

  • FDA UDI dfcc62fb-3325-4826-8800-c9ee62f966ac 35 fields · synced May 30, 2026