FDA.reportPublic FDA data

SEQUAhold WOUND CLOSURE DEVICE

Primary DI
06931132228007
Brand
SEQUAhold WOUND CLOSURE DEVICE
Company
Foshan United Medical Technologies Ltd.
Model
LKB1002
Published
2026-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MGOClosure, Wound, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGOClosure, Wound, AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06931132228007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931132228007069311322280076931132228007

GMDN Terms#

Term, Definition table
TermDefinition
Wound closure set, topicalA collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device.

Regulatory Flags#

DUNS number
421269241
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931132220063SequaFilm PU Film DressingSQ130607OU 2026-05-09
06931132222739SequaSorb Ag+ SILVER ALGINATE WOUND DRESSINGAG14102026-05-09
06931132201048Sequa® Cel10x10cmSQC10102023-09-18
06931132201079Sequa® Cel15x15cmSQC15152023-09-18
06931132201109Sequa® Cel2.5x45cmSQC25452023-09-18
06931132203042Sequa® Sorb10x10cmSQ1A10102023-09-18
06931132203073Sequa® Sorb10x20cmSQ1A10202023-09-18
06931132203103Sequa® Sorb2.5x30cmSQ1A25352023-09-18
06931132224030Kytocel10x10cm30512023-09-18
06931132224061Kytocel15x15cm30522023-09-18
06931132224092Kytocel2.5x45cm30562023-09-18
06931132201017Sequa® Cel5x5cmSQC05052023-08-25
06931132203011Sequa® Sorb5x5cmSQ1A05052023-08-25
06931132224009Kytocel5x5cm30502023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00324357410016Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410023Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410030Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410047Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410054Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00324357410061Zeni MedicalFocus Health Group, Inc.MGO2026-04-13
00850065122076Vitale CELLERA LLCMGO2025-07-17
00869193000002T-STRIPPRECISION MEDICAL DEVICES, LLCMGO2025-06-13
00850005565956VitaleCELLERA LLCMGO2023-02-15
00850005565970VitaleCELLERA LLCMGO2023-02-15
00850031608054VitaleCELLERA LLCMGO2023-02-15
00850031608573Vitale CELLERA LLCMGO2023-02-01
00850031608597Vitale CELLERA LLCMGO2023-02-01
00850031608610Vitale CELLERA LLCMGO2023-02-01
00850005565932VitaleCELLERA LLCMGO2021-11-02
00850005565901VitaleCELLERA LLCMGO2021-10-31
10080196669790MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MGO2021-05-19
40080196669791MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MGO2021-05-19