AccessGUDID - DEVICE: AESCULAP (04046963835682)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: 1050071
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1050071
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963835682
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: e9c614a3-b4ea-47ef-bd1f-0ad5cb932a8f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016