FDA.reportPublic FDA data

4Med

Primary DI
07290018281024
Brand
4Med
Company
4 MED LTD
Model
9916100
Catalog number
9916100
Device description
4Med Skin Graft Mesher Fixed ratio 1:1
Published
2020-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZWExpander, Surgical, Skin Graft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018281024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018281024072900182810247290018281024

GMDN Terms#

Term, Definition table
TermDefinition
Skin graft mesherA manual surgical device used to perforate a skin graft (a section of donor skin from another part of the patient's body) with a pattern of lacerations (cuts) before the skin is grafted to the area being treated on the patient. The skin may be placed on a skin graft carrier to better support it and will typically be run through an instrument with a row of cutting wheels, or be subjected to a rolling drum with a handle and cutting blades, to improve graft stretch and permeability and facilitate graft conformity and healing. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97286805223info@4med.co.il

Regulatory Flags#

DUNS number
532201977
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
072900182811094Med9910102-609910102-602020-09-27
072900182811234Med9910102-352020-09-27
072900182810004Med991010099101002020-09-27
072900182810174Med 991410099141002020-09-27
072900182810864Med991010299101022020-09-27
072900182811164Med9910102-609910102-602020-09-27
072900182811304Med9910102-352020-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07445161009494Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
07445161009579Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
07445161009586Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
04049197024686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
00810006780123Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780130Mesh Ex EXSURCO MEDICAL, INC.FZW2024-03-20
00810006780147Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780154Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780185Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780192Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780215Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
06975808860603MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2024-01-22
07540162040429Imperial Stackable StepstoolImperial Surgical LtdFZW2023-07-28
06975808860214MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
06975808860238MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
06975808860313MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
05033955099015Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099022Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099039Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099046Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099053Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099060Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099091Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099114Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099121Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
00855638007149Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007156Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007163Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10