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Disposable Tattoo Arm Sleeve Cover Barrier

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Disposable Tattoo Arm Sleeve Cover Barrier FDA UDI
Generic Name
Limb-worn device hygienic cover FDA UDI
Device Name
Disposable Tattoo Arm Sleeve Cover Barrier, Poly, Blue, Universal FDA UDI
Model / Reference
2137 FDA UDI
Description
Disposable Tattoo Arm Sleeve Cover Barrier, Poly, Blue, Universal FDA UDI

Identifiers

Primary DI / UDI-DI
00616784213729 FDA UDI
FDA Product Code
FXP FDA UDI
GMDN Term
Limb-worn device hygienic cover FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Limb-worn device hygienic cover

Disposable Tattoo Arm Sleeve Cover Barrier by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Limb-worn device hygienic cover.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI 8e020a52-c256-4eb2-84f8-f8dab200de36 33 fields · synced May 30, 2026