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PuraGel 5mL

FDA UDI

Class II (US FDA UDI)

by 3-D Matrix, Inc.

Identity

Trade Name
PuraGel 5mL FDA UDI
Generic Name
Synthetic peptide haemostatic agent FDA UDI
Device Name
PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml) FDA UDI
Model / Reference
651-006 FDA UDI
Description
PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml) FDA UDI

Identifiers

Catalog Number
651-006 FDA UDI
Primary DI / UDI-DI
00860001820898 FDA UDI
510(k) Number
K183015 FDA UDI
FDA Product Code
NHB FDA UDI
GMDN Term
Synthetic peptide haemostatic agent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 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

No

FDA UDI

Category: Synthetic peptide haemostatic agent

PuraGel 5mL by 3-D Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic peptide haemostatic agent.

Cleared under the same submission

K183015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3-D Matrix, Inc.

Sources (1)

  • FDA UDI 4fa3f5b5-233e-4301-ae00-05e81bb89ca8 36 fields · synced May 30, 2026