FDA.reportPublic FDA data

Mesh Ex

Primary DI
00810006780130
Brand
Mesh Ex
Company
EXSURCO MEDICAL, INC.
Model
X101836
Catalog number
X101836
Device description
ASM, Exsurco Mesher
Published
2024-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810006780130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006780130008100067801308100067801300810006780130

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-243-6049support@exsurco.com

Regulatory Flags#

DUNS number
079319210
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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
00810006780123Mesh ExX101892X1018922024-03-20
00810006780147Mesh ExX101855X1018552024-03-20
00810006780154Mesh ExX101876X1018762024-03-20
00810006780161Mesh ExX101882X1018822024-03-20
00810006780185Mesh ExX101863X1018632024-03-20
00810006780192Mesh ExX101866X1018662024-03-20
00810006780215Mesh ExX101933X1019332024-03-20
008100067800794-inch ASD Excision ring bladeX101788X1017882021-02-18
008100067800862-inch ASD Excision ring bladeX101789X1017892021-02-18
00810006780000Amalgatome SD Pneumatic HoseX101004X1010042021-01-12
00810006780017Amalgatome SD Hand Piece (Drive Unit)X101016X1010162021-01-12
00810006780024Amalgatome SD Sterilization TrayX101005X1010052021-01-12
00810006780031Amalgatome SD 2-inch Cutting HeadX100968X1009682021-01-12
00810006780048Amalgatome SD 4-inch Cutting HeadX100969X1009692021-01-12
00810006780055Amalgatome SD 2-inch Lock RingX100768X1007682021-01-12
00810006780062Amalgatome SD 4-inch Lock RingX100825X1008252021-01-12
00810006780093"Amalgatome SD System (2"" & 4"")"SDSYSTEM024SDSYSTEM0242021-01-12
108100067800764-inch ASD Excision ring bladeX101788X1017882021-02-18
108100067800832-inch ASD Excision ring bladeX101789X1017892021-02-18

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
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
00855638007170Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10