DEVICE: D-Speed (40889971051260)
Device Identifier (DI) Information
D-Speed
D-Speed
In Commercial Distribution
1051267
CARESTREAM HEALTH, INC.
D-Speed
In Commercial Distribution
1051267
CARESTREAM HEALTH, INC.
D-Speed 100 PKT 30.5X40.5MM FILM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
40978 | Dental x-ray film, non-screen |
A non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IWZ | Film, radiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 30 and 50 Percent (%) Relative Humidity |
Handling Environment Humidity: between 30 and 50 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Handling Environment Temperature: between 10 and 24 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e59a751b-e6c7-45b7-8ecc-73d86991a63f
January 19, 2022
1
January 11, 2022
January 19, 2022
1
January 11, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
60889971051264 | 50 | 40889971051260 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00889971051262
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined