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Hydrelle

FDA UDI

Class III (US FDA UDI)

by Anika Therapeutics, Inc.

Identity

Trade Name
Hydrelle FDA UDI
Generic Name
Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
Device Name
Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel FDA UDI
Model / Reference
685-015 FDA UDI
Description
Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel FDA UDI

Identifiers

Primary DI / UDI-DI
00866142000007 FDA UDI
PMA Number
P050033 FDA UDI
FDA Product Code
LMH FDA UDI
GMDN Term
Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI

Classification

Device Class
Class III 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: Dermal tissue reconstructive material, microbe-derived, anaesthetic

Hydrelle by Anika Therapeutics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, microbe-derived, anaesthetic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anika Therapeutics, Inc.

Sources (1)

  • FDA UDI 0f226487-989f-4591-9628-e12ef86b12f0 34 fields · synced Jun 9, 2026