← Back to catalogue

Oncology Portal Pack for Localization / PPL Film

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
Oncology Portal Pack for Localization / PPL Film FDA UDI
Generic Name
Medical x-ray film, non-screen FDA UDI
Device Name
Oncology PPL Film 10X12in 50SH Readypack FDA UDI
Model / Reference
Oncology Portal Pack for Localization / PPL Film FDA UDI
Description
Oncology PPL Film 10X12in 50SH Readypack FDA UDI

Identifiers

Catalog Number
8015059 FDA UDI
Primary DI / UDI-DI
40889978015050 FDA UDI
FDA Product Code
IWZ FDA UDI
GMDN Term
Medical x-ray film, non-screen FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1840 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: Medical x-ray film, non-screen

Oncology Portal Pack for Localization / PPL Film by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical x-ray film, non-screen.

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
Carestream Health, Inc.

Sources (1)

  • FDA UDI 0d6ba8f7-4e17-4068-b5f9-a59a9c7e38da 35 fields · synced Jun 8, 2026