FDA.reportPublic FDA data

DYNA-FLEX™

Primary DI
15051978003427
Brand
DYNA-FLEX™
Company
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Model
7025
Device description
Multi-Layer Compression System
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCYWound Dressing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55051978003425PackageGS18In Commercial Distribution
15051978003427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5505197800342555051978003425
1505197800342715051978003427

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of non-sterile bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866 978 3296xx@xx.xx

Regulatory Flags#

DUNS number
211352227
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051978001089FIBRACOL® PLUS298129812019-09-24
15051978001096FIBRACOL® PLUS298229822019-09-24
15051978001102FIBRACOL® PLUS298329832019-09-24
15051978001119FIBRACOL® PLUS298429842019-09-24
15051978002833PROMOGRAN PRISMA®MA028MA0282019-09-24
15051978002888PROMOGRAN PRISMA®MA123MA1232019-09-24
15051978003083PROMOGRAN®PG004PG0042019-09-24
15051978003090PROMOGRAN®PG019PG0192019-09-24
15051978009993PROMOGRAN PRISMA®MA032MA0322019-09-24
15051978006428BIOCLUSIVE® PLUSBIP0607BIP06072019-09-24
15051978006435BIOCLUSIVE® PLUSBIP1012BIP10122019-09-24
15051978006442BIOCLUSIVE® PLUSBIP1520BIP15202019-09-24
15051978006459BIOCLUSIVE® PLUSBIP2030BIP20302019-09-24
15051978002543NU-DERM® HCB102HCB1022019-09-24
15051978002550NU-DERM® HCB106HCB1062019-09-24
15051978002567NU-DERM® HCS100HCS1002019-09-24
15051978002574NU-DERM®HCT101HCT1012019-09-24
15051978002581NU-DERM® HCB108HCB1082019-09-24
15051978002604NU-DERM® HCB204HCB2042019-09-24
15051978002611NU-DERM® HCH207HCH2072019-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459428623MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459433474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10198459171789Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
10653160381518MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
10198459057939Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
10195327657833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10195327667924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10198459053849Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
10195327559182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
10193489360479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
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10195327297725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-13
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10193489423600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-06-08
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