Syvek Radial Patch

GUDID 00389142000018

Syvek Radial Patch

MARINE POLYMER TECHNOLOGIES, INC.

Plant polysaccharide haemostatic agent, non-bioabsorbable
Primary Device ID00389142000018
NIH Device Record Keyf0771648-5b55-42af-89db-70d681cbbb3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyvek Radial Patch
Version Model Number400-29
Company DUNS809739386
Company NameMARINE POLYMER TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100389142000018 [Primary]
GS110389142000015 [Package]
Package: box [20 Units]
In Commercial Distribution

FDA Product Code

NACDressing, Wound, Hydrophilic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-13
Device Publish Date2020-02-05

Devices Manufactured by MARINE POLYMER TECHNOLOGIES, INC.

10389142000039 - Syvek Brace with Straps2020-10-30 Syvek Brace with Straps
10389142000190 - Talymed 10 cm x 10 cm2020-09-08 Talymed 10 cm x 10 cm
10389142000046 - Talymed 3 cm x 3 cm 2020-09-08 Talymed 3 cm x 3 cm
10389142000114 - mrdh bandage 10 cm x 10 cm2020-04-17 mrdh Bandage 10 cm x 10 cm (4" x 4")
10389142000121 - mrdh Bandage 5 cm x 5 cm2020-04-17 mrdh bandage 5 cm x 5 cm (2 "x 2")
00389142000209 - Talymed dressing 5 cm x 5 cm2020-04-16 Talymed dressing 5 cm x 5 cm
00389142000018 - Syvek Radial Patch2020-02-13Syvek Radial Patch
00389142000018 - Syvek Radial Patch2020-02-13 Syvek Radial Patch
20389142000067 - Syvek Excel Patch2020-01-28 Syvek Excel Patch

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.