Kytocel;Seque® San 3050

GUDID 06931132224009

Foshan United Medical Technologies Ltd.

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID06931132224009
NIH Device Record Key91c8a0d5-1825-40d8-8dd1-b0c889cfc923
Commercial Distribution StatusIn Commercial Distribution
Brand NameKytocel;Seque® San
Version Model Number5x5cm
Catalog Number3050
Company DUNS421269241
Company NameFoshan United Medical Technologies Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106931132224009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-04
Device Publish Date2023-08-25

Devices Manufactured by Foshan United Medical Technologies Ltd.

06931132201048 - Sequa® Cel2023-09-26
06931132201079 - Sequa® Cel2023-09-26 Sequa®Cel CMC Dressing is a sterile nonwoven wound dressing composed of 100% Carboxymethyl Cellulose (CMC) fibers. The Sequa®C
06931132201109 - Sequa® Cel2023-09-26 Sequa®Cel CMC Dressing is a sterile nonwoven wound dressing composed of 100% Carboxymethyl Cellulose (CMC) fibers. The Sequa®C
06931132203042 - Sequa® Sorb2023-09-26 Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength al
06931132203073 - Sequa® Sorb2023-09-26 Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength al
06931132203103 - Sequa® Sorb2023-09-26 Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength al
06931132224030 - Kytocel2023-09-26
06931132224061 - Kytocel2023-09-26

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