← Back to catalogue

Oec

FDA UDI

Class II (US FDA UDI)

by Tidi Products, Llc

Identity

Trade Name
OEC FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
OEC MiniView C-Arm 15cm with Worksurface Extension Drape, Intended For Use With: OEC MiniView FDA UDI
Model / Reference
31049 FDA UDI
Description
OEC MiniView C-Arm 15cm with Worksurface Extension Drape, Intended For Use With: OEC MiniView FDA UDI

Identifiers

Catalog Number
8849779 FDA UDI
Primary DI / UDI-DI
00618125190751 FDA UDI
FDA Product Code
PUI FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

No

FDA UDI

Over-the-Counter

Yes

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

Oec by Tidi Products, Llc — Class II — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tidi Products, Llc

Sources (1)

  • FDA UDI db8cbe16-99aa-41b3-9e4b-8501636c3dab 34 fields · synced May 31, 2026