AccessGUDID - DEVICE: PREVELEAK SURGICAL SEALANT (05413765583520)

GUDID

Device Identifier (DI) Information

Brand Name: PREVELEAK SURGICAL SEALANT
Version or Model: ADS201807
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADS201807
Company Name: Baxter Healthcare Corporation

Primary DI Number: 05413765583520
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 117472302 *Terms of Use

Device Description: The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products.

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
NBE	Sealant, polymerizing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100030	014

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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8820c7f1-ae6a-42f5-9e26-49583a94a3d1
Public Version Date: July 19, 2023
Public Version Number: 2
DI Record Publish Date: February 22, 2022