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Skin Test

FDA UDI

Class III (US FDA UDI)

by Suneva Medical, Inc.

Identity

Trade Name
SKIN TEST FDA UDI
Generic Name
Dermal tissue reconstructive material, animal-derived FDA UDI
Device Name
Skin Test 0.3ml in 1.0cc syringe FDA UDI
Model / Reference
0.3cc FDA UDI
Description
Skin Test 0.3ml in 1.0cc syringe FDA UDI

Identifiers

Catalog Number
GBS0501 FDA UDI
Primary DI / UDI-DI
00350224000035 FDA UDI
FDA Product Code
LMH FDA UDI
GMDN Term
Dermal tissue reconstructive material, animal-derived 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, animal-derived

Skin Test by Suneva Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, animal-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suneva Medical, Inc.

Sources (1)

  • FDA UDI ca26e21a-0bc2-4978-bb88-19f747ae5554 36 fields · synced May 30, 2026