FDA.reportPublic FDA data

Dynamic Tissue Systems™

Primary DI
10620974002328
Brand
Dynamic Tissue Systems™
Company
Southmedic Incorporated
Model
SWA07-20
Catalog number
SWA07-20
Device description
ABRA Button Tail
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
KGSRETENTION DEVICE, SUTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10620974002328PrimaryGS10
00620974002321Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400232810620974002328
00620974002321006209740023216209740023210620974002321

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closing tension deviceA sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
246848147
Device count
10
Premarket exempt
true
Lot or batch
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
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
00860011629412V-CloseDRS Vascular, Inc.KGS2026-03-09
10860011629419V-CloseDRS Vascular, Inc.KGS2026-03-09
00810178880652ViveVIVE HEALTH LLCKGS2026-02-05
00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
00850012846680SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007140LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
00860007834233SUTUREGARD(R) Classic Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
00860007834240SUTUREGARD(R) Hammerhead(TM) Adhesive Suture Retention DeviceSUTUREGARD MEDICAL, INCKGS2025-10-03
10888277381766MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
10884450786199Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
00860011629405Q-StopDRS Vascular, Inc.KGS2024-05-23
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
00630094199818Bioseal Inc.BIOSEALKGS2023-12-19
00630094199832Bioseal Inc.BIOSEALKGS2023-12-19
00630094199863Bioseal Inc.BIOSEALKGS2023-12-19
00630094199870Bioseal Inc.BIOSEALKGS2023-12-19
00630094199894Bioseal Inc.BIOSEALKGS2023-12-19
10630094199815Bioseal Inc.BIOSEALKGS2023-12-19
10630094199839Bioseal Inc.BIOSEALKGS2023-12-19
10630094199860Bioseal Inc.BIOSEALKGS2023-12-19
10630094199877Bioseal Inc.BIOSEALKGS2023-12-19
10630094199891Bioseal Inc.BIOSEALKGS2023-12-19
00630094199719Bioseal Inc.BIOSEALKGS2023-12-12
00630094199733Bioseal Inc.BIOSEALKGS2023-12-12
00630094199757Bioseal Inc.BIOSEALKGS2023-12-12
00630094199788Bioseal Inc.BIOSEALKGS2023-12-12