REGENX PuraKOTE

FDA UDI

Class II (US FDA UDI)

by Ace Surgical Supply Co., Inc.

Identity

Trade Name: REGENX PuraKOTE FDA UDI
Generic Name: General oral wound dressing, animal-derived FDA UDI
Device Name: PuraTAPE 25x75x1mm, 10/BX Collagen Dental Dressing FDA UDI
Model / Reference: PGTPE1 FDA UDI
Description: PuraTAPE 25x75x1mm, 10/BX Collagen Dental Dressing FDA UDI

Identifiers

Catalog Number: PGTPE1 FDA UDI
Primary DI / UDI-DI: 00614950008728 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: General oral wound dressing, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 40 Millimeter FDA UDI
Width — 20 Millimeter FDA UDI
Length — 75 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

Category: General oral wound dressing, animal-derived

REGENX PuraKOTE by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General oral wound dressing, animal-derived.

HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
Symbios® Collagen Tape — Dentsply Implants Manufacturing GmbH · U
creos™ — Integra Lifesciences Corp. · Class III
CollaPlug® — Integra Lifesciences Corp. · Class III
GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U
Curagen collagen wound dressing — MAXIGEN BIOTECH INC. · U
HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
NeoGen Plug — COLLAGEN MATRIX, INC. · U

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ace Surgical Supply Co., Inc.

Sources (1)

FDA UDI 0d537c15-58ba-4519-9aff-04a1b1a3bc41 36 fields · synced May 30, 2026