DEVICE: AESCULAP (04046963835682)
Device Identifier (DI) Information
AESCULAP
1050071
Not in Commercial Distribution
1050071
B BRAUN SURGICAL SA
1050071
Not in Commercial Distribution
1050071
B BRAUN SURGICAL SA
HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58777 | Surgical internal adhesive/sealant, synthetic polymer |
A 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 might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MPN | Tissue adhesive for the topical approximation of skin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 22 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Volume : 0.500 ML |
Device Size Text, specify: Raw material : n-butyl-2-cyanoacrylate |
Device Record Status
e9c614a3-b4ea-47ef-bd1f-0ad5cb932a8f
March 18, 2025
7
September 24, 2016
March 18, 2025
7
September 24, 2016
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 | 2025-01-16 | Not in Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046963656713
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com