Primary Device ID | 60889971545749 |
NIH Device Record Key | ee902caf-c84b-4778-afe2-eea2931b93cc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Half Blue X-ray Film WB |
Version Model Number | Half Blue X-ray Film WB |
Catalog Number | 1545748 |
Company DUNS | 793169512 |
Company Name | CARESTREAM HEALTH, INC. |
Device Count | 100 |
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 | 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 |
Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 60 Percent (%) Relative Humidity and 0 |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 0 |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Handling Environment Humidity | Between 60 Percent (%) Relative Humidity and 0 |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 0 |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00889971545747 [Unit of Use] |
GS1 | 40889971545745 [Primary] |
GS1 | 60889971545749 [Package] Contains: 40889971545745 Package: Case [5 Units] In Commercial Distribution |
IWZ | Film, radiographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-16 |
60889971623867 | 100SH 11X14IN HALF BLUE X-RAY |
60889971605382 | 100SH 18X43-7X17 HALF BLUE X-RAY |
60889971545749 | 100SH 24X30CM HALF BLUE X-RAY |
60889971246363 | 100SH 35X43-14X17 HALF BLUE X-RAY |
60889971205193 | 25SH 14X36IN HALF BLUE X-RAY |
60889971118349 | 100SH 10X12IN HALF BLUE X-RAY |
60889971088673 | 100SH 8X10IN HALF BLUE X-RAY |