Imaging Plate 8770711

GUDID 60889978770717

CR IMAGING PLATE PAN V2 5X12IN

CARESTREAM HEALTH, INC.

Digital imaging storage phosphor screen Digital imaging storage phosphor screen
Primary Device ID60889978770717
NIH Device Record Keybfd89aac-5d07-47a9-99e0-5706b637ceee
Commercial Distribution StatusIn Commercial Distribution
Brand NameImaging Plate
Version Model NumberImaging Plate
Catalog Number8770711
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS160889978770717 [Primary]

FDA Product Code

EAMScreen, intensifying, radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

On-Brand Devices [Imaging Plate]

60889978770717CR IMAGING PLATE PAN V2 5X12IN
60889978464913CR IMAGING PLATES CEPH 8X10IN
60889978304899CR IMAGING PLATES PAN 5X12IN
60889978025428CR IMAGING PLATES CEPH 18X24CM
6088997125169510SC 10X12 UB REPLACE PHSPHR CR SCN
60889978610099(2) SZ 3 DENTAL CR I/O IMAG PLATES
60889978406845(2) SZ 1 DENTAL CR I/O IMAG PLATES
60889971683373(2) SZ 4 DENTAL CR I/O IMAG PLATES
60889971435408CR SEMI-FIN PLATE CEPH 8X10IN
60889971340078(2) SZ 2 DENTAL CR I/O IMAG PLATES
60889971098917CR SEMI-FIN PLATE CEPH 18X24CM
60889971067562Imaging Plate #2 - 4 Pcs
60889971067555Imaging Plate #1 - 4 Pcs
60889971067548Imaging Plate #0 - 4 Pcs

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.