AccessGUDID - DEVICE: AESCULAP (04046963790950)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: TS1050071FP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TS1050071FP
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963790950
Issuing Agency: GS1
Commercial Distribution End Date: February 24, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: HISTOACRYL CLEAR SKIN ADHESIVE (FP)

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 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

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: Raw material : n-butyl-2-cyanoacrylate
Device Size Text, specify: Volume : 0.500 ML

Device Record Status

Public Device Record Key: b76c341f-5253-4a25-966d-5bcb61f77be0
Public Version Date: February 28, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016