DEVICE: PREVELEAK SURGICAL SEALANT (05413765583520)
Device Identifier (DI) Information
PREVELEAK SURGICAL SEALANT
ADS201807
In Commercial Distribution
ADS201807
Baxter Healthcare Corporation
ADS201807
In Commercial Distribution
ADS201807
Baxter Healthcare Corporation
The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBE | Sealant, polymerizing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P100030 | 014 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8820c7f1-ae6a-42f5-9e26-49583a94a3d1
July 19, 2023
2
February 22, 2022
July 19, 2023
2
February 22, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
25413765583524 | 10 | 05413765583520 | In Commercial Distribution | PACK |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
75413765583529
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
medinfo_medproducts@baxter.com
medinfo_medproducts@baxter.com