FDA.reportPublic FDA data

Dynamic Tissue Systems™

Primary DI
00620974001737
Brand
Dynamic Tissue Systems™
Company
Southmedic Incorporated
Model
DWC38
Catalog number
DWC38
Device description
DynaClose Set
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKYSYSTEM, SKIN CLOSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10620974001734PackageGS115In Commercial Distribution
00620974001737PrimaryGS10
20620974001731Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400173410620974001734
00620974001737006209740017376209740017370620974001737
2062097400173120620974001731

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.

Contacts#

Phone, Email table
PhoneEmail
+1(705)726-9383custserv@southmedic.com

Regulatory Flags#

DUNS number
246848147
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10620974004483Southmedic Instrument Cleaning BrushesPK45601PK456012026-05-19
10620974004490Southmedic Instrument Cleaning BrushesPK456000PK4560002026-05-19
10620974004551Southmedic Instrument Cleaning BrushesPK45304NSPK45304NS2026-05-19
10620974004568Southmedic Instrument Cleaning BrushesPK45306PK453062026-05-19
10620974003349SPSS Safety Scalpel Metal Handle73-8041-173-8041-12023-02-07
10620974001338Southmedic Instrument Cleaning BrushesPK45DS01PK45DS012026-01-07
10620974004506Southmedic Instrument Cleaning BrushesPK45DS02PK45DS022026-01-07
10620974004513Southmedic Instrument Cleaning BrushesPK45DS03PK45DS032026-01-07
10620974004520Southmedic Instrument Cleaning BrushesPK45DS04PK45DS042026-01-07
10620974004537Southmedic Instrument Cleaning BrushesPK45DS05PK45DS052026-01-07
10620974004285BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
00620974004288BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
10620974002069BetterShield™MXFS-FOAMMXFS-FOAM2020-10-02
10620974002076BetterShield™MXFS-50-FOAMMXFS-50-FOAM2020-10-02
10620974002083BetterShield™MXFS-SAMPLEMXFS-SAMPLE2020-10-02
00620974002048BetterShield™MXFS-25MXFS-252020-10-02
10620974004322Southmedic Instrument Cleaning BrushesPK45602PK456022025-08-28
10620974004339Southmedic Instrument Cleaning BrushesPK45603PK456032025-08-28
10620974004346Southmedic Instrument Cleaning BrushesPK45604PK456042025-08-28
10620974004353Southmedic Instrument Cleaning BrushesPK45605PK456052025-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007834257SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
10860007834254SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
06972864363024sknjxNingbo Chinmed Technology Co., Ltd.MKY2025-11-20
00844735006728DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
00844735006735DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
07540161750015AbCloInventorr MD IncMKY2023-12-04
00840118605175ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611435ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611459ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611473ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611497ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611510ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611534ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611558ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613644ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118605182ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611442ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611466ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611480ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611503ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611527ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611541ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
08800125000020DIALFIX 11DFIXMKY2023-01-28
08800125000037DIALFIX 15DFIXMKY2023-01-28
08800125000044DIALFIX 18DFIXMKY2023-01-28
08800125000051DIALFIX 21DFIXMKY2023-01-28
08800125000068DIALFIX 24DFIXMKY2023-01-28
08800125000075DIALFIX PLUS 3DFIXMKY2023-01-28