AccessGUDID - DEVICE: BioGlue Surgical Adhesive (00877234000164)

GUDID

Device Identifier (DI) Information

Brand Name: BioGlue Surgical Adhesive
Version or Model: BGAT-10-SY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BGAT-10-SY
Company Name: Artivion, Inc.

Primary DI Number: 00877234000164
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: BioGlue Surgical Adhesive Syringe Extender 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:	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?
44830	Open-surgery adhesive/sealant applicator, dual-channel	A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUQ	Glue,Surgical,Arteries

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010003	006
P010003	022
P010003	027
P010003	028

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
Length: 10 Centimeter

Device Record Status

Public Device Record Key: 98af8ff6-d34d-44c0-8624-55ab5e0bde1d
Public Version Date: March 14, 2024
Public Version Number: 5
DI Record Publish Date: December 12, 2016