AccessGUDID - DEVICE: BioGlue Surgical Adhesive (00877234000232)

GUDID

Device Identifier (DI) Information

Brand Name: BioGlue Surgical Adhesive
Version or Model: BG3502-5-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BG3502-5-US
Company Name: Artivion, Inc.

Primary DI Number: 00877234000232
Issuing Agency: GS1
Commercial Distribution End Date: February 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

Device Description: 2mL Syringe and Standard Applicator Tips

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
47784	Surgical internal adhesive/sealant, animal-derived	A bioabsorbable substance containing animal-derived material [e.g., bovine serum albumin (BSA)/cross-linking agent] intended to be used for internal surgical applications to bond or seal cut, incised, or resected body tissues (e.g., for vascular anastomosis) typically as an adjunct to standard methods of closure, to seal leaks, and might in addition be intended to achieve haemostasis through tissue sealing. Disposable mixing devices/applicators may be included for preparation and application to anatomical sites. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MUQ	Glue,Surgical,Arteries

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010003	001
P010003	002
P010003	003
P010003	004
P010003	007
P010003	008
P010003	009
P010003	012
P010003	013
P010003	014
P010003	015
P010003	020
P010003	021
P010003	022
P010003	023
P010003	024
P010003	025
P010003	027
P010003	029

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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: 6ab512da-7ba4-46dd-8ee1-e47c9486f277
Public Version Date: March 14, 2024
Public Version Number: 6
DI Record Publish Date: December 12, 2016