FDA.reportPublic FDA data

Dynamic Tissue Systems™

Primary DI
00620974001782
Brand
Dynamic Tissue Systems™
Company
Southmedic Incorporated
Model
DCNE-01
Catalog number
DCNE-01
Device description
DynaCleft Nasal Elevation System
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
MZRTOPICAL APPROXIMATION SYSTEM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZRTopical Approximation SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10620974001789PackageGS11In Commercial Distribution
00620974001782PrimaryGS10
20620974001786Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400178910620974001789
00620974001782006209740017826209740017820620974001782
2062097400178620620974001786

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
7
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
00850019787009Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787016Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787023Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787030Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787047Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787054Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787061Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787078Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787085Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787092Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787115Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787313Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860002036526Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860002036540Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860002036595Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860010953938LipAlignCleftalign Inc.MZR2024-08-20
00860010953945LipAlignCleftalign Inc.MZR2024-08-20
00860010953952LipAlignCleftalign Inc.MZR2024-08-20
00860010953907NoseAlignCleftalign Inc.MZR2023-11-24
00860010953914NoseAlignCleftalign Inc.MZR2023-11-24
00860010953921NoseAlignCleftalign Inc.MZR2023-11-24
05000223448974LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449063LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449124LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449155LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449216LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449643LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449674LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223448981LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449070LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19