DEVICE: Henry Schein (00304040025970)

Device Identifier (DI) Information

Henry Schein
5700347
In Commercial Distribution
5700347
HENRY SCHEIN, INC.
00304040025970
GS1

1
012430880 *Terms of Use
Retreat GRP Starter Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Gingival retraction kit A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MVL CORD, RETRACTION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050180 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: capsules containing 1g of EXPASYL paste
Weight: 1 Gram
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Device Record Status

32db4a2f-0e3a-4ca5-9f79-52a460631ad8
July 06, 2018
3
September 24, 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
No Package DIs found
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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