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 ID: 00812045030115
• NIH Device Record Key: e20efe1f-6c4c-4618-aaa4-5947ad1f306d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DX-58 ADULT PAPER PAK
• Version Model Number: 18001
• Company DUNS: 010016319
• Company Name: Flow X Ray Corporation
• Device Count: 150
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812045030115 [Primary]
GS1	10812045030112 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	20812045030119 [Unit of Use]

FDA Product Code

• IWZ: Film, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

Devices Manufactured by Flow X Ray Corporation

• 00081204503900 - DV-58 ADULT ECONO PAK: 2023-08-17 D Speed, Size 2, 600 Single Film Packets.
• 00812045030115 - DX-58 ADULT PAPER PAK: 2023-08-17D Speed, Size 2, 150 Single Film Paper Packets.
• 00812045030115 - DX-58 ADULT PAPER PAK: 2023-08-17 D Speed, Size 2, 150 Single Film Paper Packets.
• 00812045030634 - DX-42 BITE CHEX: 2023-08-17 D Speed, Size 3, 100 Single Film Paper Packets
• 00812045030832 - DV-57 ADULT TWIN VALUE PAK: 2023-08-17 D Speed, Size 2, 130 Double Film Packets.
• 00812045030849 - DV-53 CHILD TWIN PEDO PAK: 2023-08-17 D Speed, Size 0, 100 Double Film Packets.
• 00812045030856 - DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET: 2023-08-17 D Speed, Size 0, 75 Single Film Butterfly Barrier Packets
• 00812045030863 - DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET: 2023-08-17 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.