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Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes

FDA UDI

Class I (US FDA UDI)

by Omnia Spa

Identity

Trade Name
Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes FDA UDI
Model / Reference
12.U0014.00 FDA UDI
Description
Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes FDA UDI

Identifiers

Primary DI / UDI-DI
08056646508679 FDA UDI
FDA Product Code
KGT FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment/instrument drape, single-use

Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes by Omnia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment/instrument drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omnia Spa

Sources (1)

  • FDA UDI c14e13df-c6ec-4242-86de-ff0afcd06a99 33 fields · synced May 30, 2026