FDA.reportPublic FDA data

Skin Closure Strips

Primary DI
36937935329584
Brand
Skin Closure Strips
Company
Shanghai Iso Medical Products Co., Ltd.
Model
3x76mm
Device description
Non-Reinforced
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36937935329584PackageGS150In Commercial Distribution
56937935329588PackageGS14In Commercial Distribution
06937935329583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3693793532958436937935329584
5693793532958856937935329588
06937935329583069379353295836937935329583

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closure adhesive stripA small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420364846
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937935319003Silicone Foam Dressing with Adhesive Border46-9222025-10-29
06937935319010Silicone Foam Dressing with Adhesive Border46-9332025-10-29
06937935319027Silicone Foam Dressing with Adhesive Border46-9442025-10-29
06937935319034Silicone Foam Dressing with Adhesive Border46-9662025-10-29
06937935319041Silicone Foam Dressing with Adhesive Border46-94102025-10-29
06937935319058Silicone Foam Sacral Dressing with Adhesive Border46-9772025-10-29
06937935319065Silicone Foam Sacral Dressing with Adhesive Border46-9992025-10-29
06937935319072Silicone Foam Heel Dressing with Adhesive Border46-9792025-10-29
06937935319089Silicone Foam Dressing46-944N2025-10-29
06937935319096Silicone Foam Dressing46-966N2025-10-29
06937935319102Silicone Foam Oval Dressing with Adhesive Border46-9242025-10-29
06937935319119Silicone Foam Dressing with Adhesive Border46-922L2025-10-29
06937935319126Silicone Foam Dressing with Adhesive Border46-944L2025-10-29
06937935319133Silicone Foam Dressing with Adhesive Border46-966L2025-10-29
06937935328715Transparent Adhesive Film DressingTF22502025-01-22
06937935328722Transparent Adhesive Film DressingTF221002025-01-22
06937935328739Transparent Adhesive Film DressingTF4475202025-01-22
06937935328746Transparent Adhesive Film DressingTF4475502025-01-22
06937935328753Transparent Adhesive Film DressingTF44751002025-01-22
06937935328760Transparent Adhesive Film DressingTF86102025-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20