DEVICE: Defend (00843471130988)

Device Identifier (DI) Information

Defend
BF-8700
In Commercial Distribution
BF-8700
Young Innovations, Inc.
00843471130988
GS1

1
004193103 *Terms of Use
Barrier Envelopes for phosphor storage plate Size 0
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
45256 Digital imaging cassette/storage phosphor screen, dental
A combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
EGZ Holder, film, x-ray
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

7d54b8d7-02f3-40a3-91de-e7e4174f2580
November 07, 2022
1
October 30, 2022
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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
10843471130985 100 00843471130988 In Commercial Distribution Box
20843471130982 100 10843471130985 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1 (800) 275-0020
customerservice@defend.com
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