AccessGUDID - DEVICE: Coseal Surgical Sealant Extended Applicator (00085412083339)

GUDID

Device Identifier (DI) Information

Brand Name: Coseal Surgical Sealant Extended Applicator
Version or Model: 934034
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 934034
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412083339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 628013963 *Terms of Use

Device Description: The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components.

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?
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
NBE	Sealant,Polymerizing

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
Special Storage Condition, Specify: Store at room temperature (approximately 25 degrees celsius)

Clinically Relevant Size

[?]

Size Type Text
Length: 22 Centimeter

Device Record Status

Public Device Record Key: c7219c2b-9e8a-430f-829c-dd2c235b2227
Public Version Date: July 27, 2023
Public Version Number: 4
DI Record Publish Date: October 09, 2017