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Syvek SP Patch

FDA UDI

Class I (US FDA UDI)

by Marine Polymer Technologies, Inc.

Identity

Trade Name
Syvek SP Patch FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
Device Name
Syvek SP Patch FDA UDI
Model / Reference
400-12 FDA UDI
Description
Syvek SP Patch FDA UDI

Identifiers

Primary DI / UDI-DI
00389142000100 FDA UDI
FDA Product Code
NAC FDA UDI
GMDN Term
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4018 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

Yes

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 SP 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 ae439006-8bdf-45f1-866c-cca36417f600 34 fields · synced Jun 6, 2026