DEVICE: Henry Schein (00304040036044)

Device Identifier (DI) Information

Henry Schein
5700351
In Commercial Distribution
5700351
HENRY SCHEIN, INC.
00304040036044
GS1

1
012430880 *Terms of Use
Topical Skin Adh Flex w/Tip
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Device Characteristics

MR Conditional
No
Yes
Yes
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
Dermal surgical adhesive/sealant applicator A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MPN Tissue adhesive for the topical approximation of skin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Peracetic Acid
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not exceed 22 deg C
Storage Environment Temperature: between 0 and 22 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.5 Milliliter
Device Size Text, specify: Ampoule 0.5ml, 10/box
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Device Record Status

2bd253da-c79d-4a0b-be1c-e7fcd8a52030
March 29, 2018
2
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
10304040036041 10 00304040036044 In Commercial Distribution
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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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