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DynaGinate Calcium Alginate Dressing

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
DynaGinate Calcium Alginate Dressing FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
Device Name
DynaGinate Calcium Alginate Dressing, 4"x8" FDA UDI
Model / Reference
3028 FDA UDI
Description
DynaGinate Calcium Alginate Dressing, 4"x8" FDA UDI

Identifiers

Primary DI / UDI-DI
00616784302812 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

DynaGinate Calcium Alginate Dressing by Dynarex Corp. — 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
Dynarex Corp.

Sources (1)

  • FDA UDI acbfa5e1-74dc-482a-bd99-0bee34939caa 33 fields · synced Jun 1, 2026