DEVICE: AESCULAP (04046963835682)

Device Identifier (DI) Information

AESCULAP
1050071
In Commercial Distribution
1050071
B BRAUN SURGICAL SA
04046963835682
GS1

10
511268005 *Terms of Use
HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Surgical adhesive/sealant, synthetic polymer A sterile, biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and/or to achieve haemostasis. It is applied using a dedicated applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. 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
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 22 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Volume : 0.500 ML
Device Size Text, specify: Raw material : n-butyl-2-cyanoacrylate
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Device Record Status

e9c614a3-b4ea-47ef-bd1f-0ad5cb932a8f
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
04046963656720 50 04046963835682 In Commercial Distribution Carton
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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: 04046963656713 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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