DEVICE: Henry Schein (00304040006412)

Device Identifier (DI) Information

Henry Schein
1126111
In Commercial Distribution
1126111
HENRY SCHEIN, INC.
00304040006412
GS1

1
012430880 *Terms of Use
Topical Skin Adhesive Blue
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Device Characteristics

MR Conditional
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34164 Skin-approximation adhesive
A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.
Active false
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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 22degreeC
Storage Environment Temperature: between 0 and 22 Degrees Celsius
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Clinically Relevant Size

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

eaf1d4c6-0dae-4ef8-b38f-b703f0ef85d8
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
10304040006419 10 00304040006412 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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