LANEX Fast Screens 1013150

GUDID 60889971013156

10SC 17X17 LX FST BK SCNT SC F/VAR

CARESTREAM HEALTH, INC.

X-ray intensifying screen

• Primary Device ID: 60889971013156
• NIH Device Record Key: efcad727-cccb-433c-abff-c37754fbce47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANEX Fast Screens
• Version Model Number: LANEX Fast Screens
• Catalog Number: 1013150
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 10
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00889971013154 [Unit of Use]
GS1	60889971013156 [Primary]

FDA Product Code

• EAM: Screen, intensifying, radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [LANEX Fast Screens]

• 60889978549610: SG 16.22X16.22 LFTB C2W/OF/T/CC N/M
• 60889978371693: SGL32.5X42.5CM LNX FS BC2W/OFM/T/CC
• 60889971476173: PR 35X43CM LANEX FAST SCREEN C1
• 60889971163882: PR 14X36 LANEX FAST SCR C2 W/O FOAM
• 60889971160683: PR 14X17 LANEX FAST SCR C2 W/O FOAM
• 60889971160447: PR 11X14 LANEX FAST SCR C2 W/O FOAM
• 60889971157980: PR 10X12 LANEX FAST SCR C2 W/O FOAM
• 60889971156570: PR 8X10 LANEX FAST SCR C2 W/O FOAM
• 60889971013156: 10SC 17X17 LX FST BK SCNT SC F/VAR