DEVICE: X-OMAT DBF (40889971990712)

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Device Record History
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Device Identifier (DI) Information
X-OMAT DBF
X-OMAT DBF
In Commercial Distribution
1990712
CARESTREAM HEALTH, INC.
40889971990712
GS1

50
793169512 *Terms of Use
X-OMAT DBF 50SH 15x30cm film
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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?
40977 Dental x-ray film, screen
A screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed to be sensitive primarily to the wavelengths of light emitted from an image intensifying screen. This x-ray film 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
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FDA Product Code

[?]
Product Code Product Code Name
IWZ Film, radiographic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 10 and 24 Degrees Celsius
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: more than 30 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c4a171fd-eba7-413e-a463-ea1cb532b24f
March 29, 2018
2
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
60889971990716 10 40889971990712 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00889971990714 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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