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Orfit Industries

FDA UDI

Class II (US FDA UDI)

by Orfit Industries NV

Identity

Trade Name
Orfit Industries FDA UDI
Generic Name
DNA-based tissue typing IVD, reagent FDA UDI
Device Name
Prone Breast board - Cranial Cushion Elevation FDA UDI
Model / Reference
29005-V2 FDA UDI
Description
Prone Breast board - Cranial Cushion Elevation FDA UDI

Identifiers

Primary DI / UDI-DI
05420028711620 FDA UDI
510(k) Number
K191158 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
DNA-based tissue typing IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: DNA-based tissue typing IVD, reagent

Orfit Industries by Orfit Industries NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as DNA-based tissue typing IVD, reagent.

Cleared under the same submission

K191158 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orfit Industries NV

Sources (1)

  • FDA UDI 70f4e8ab-cc9e-4877-aa43-6cc173907c44 35 fields · synced May 30, 2026