DX-58 ADULT PAPER PAK

GUDID 00812045030115

D Speed, Size 2, 150 Single Film Paper Packets.

Flow X Ray Corporation

Dental x-ray film, non-screen
Primary Device ID00812045030115
NIH Device Record Keye20efe1f-6c4c-4618-aaa4-5947ad1f306d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDX-58 ADULT PAPER PAK
Version Model Number18001
Company DUNS010016319
Company NameFlow X Ray Corporation
Device Count150
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812045030115 [Primary]
GS110812045030112 [Package]
Package: [50 Units]
In Commercial Distribution
GS120812045030119 [Unit of Use]

FDA Product Code

IWZFilm, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

Devices Manufactured by Flow X Ray Corporation

00081204503900 - DV-58 ADULT ECONO PAK2023-08-17 D Speed, Size 2, 600 Single Film Packets.
00812045030115 - DX-58 ADULT PAPER PAK2023-08-17D Speed, Size 2, 150 Single Film Paper Packets.
00812045030115 - DX-58 ADULT PAPER PAK2023-08-17 D Speed, Size 2, 150 Single Film Paper Packets.
00812045030634 - DX-42 BITE CHEX2023-08-17 D Speed, Size 3, 100 Single Film Paper Packets
00812045030832 - DV-57 ADULT TWIN VALUE PAK2023-08-17 D Speed, Size 2, 130 Double Film Packets.
00812045030849 - DV-53 CHILD TWIN PEDO PAK2023-08-17 D Speed, Size 0, 100 Double Film Packets.
00812045030856 - DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET2023-08-17 D Speed, Size 0, 75 Single Film Butterfly Barrier Packets
00812045030863 - DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET2023-08-17 D Speed, Size 2, 100 Single Film Butterfly Barrier Packets.
00812045030870 - DUPLICATING FILM, 14 X 17"2023-08-17 Duplicating Film, 14x17", 100 sheets per box.

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