DEVICE: Henry Schein (00304040006382)

Device Identifier (DI) Information

Henry Schein
1126933
In Commercial Distribution
1126933
HENRY SCHEIN, INC.
00304040006382
GS1

1
012430880 *Terms of Use
Topical Skin Adhesive
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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
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.
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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
Storage Environment Temperature: between 0 and 22 Degrees Celsius
Special Storage Condition, Specify: Do not exceed 22degreeC
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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

7b8849c4-e2dd-474a-8429-0b7dec383676
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
10304040006389 10 00304040006382 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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