FDA.reportPublic FDA data

Mesh Ex

Primary DI
00810006780161
Brand
Mesh Ex
Company
EXSURCO MEDICAL, INC.
Model
X101882
Catalog number
X101882
Device description
Tray, Sterilization 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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810006780161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006780161008100067801618100067801610810006780161

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
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
00810006780130Mesh Ex X101836X1018362024-03-20
00810006780147Mesh ExX101855X1018552024-03-20
00810006780154Mesh ExX101876X1018762024-03-20
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
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
18257200028177PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028207PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028917FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028924FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028931FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028948FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028955FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028979FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028986FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028993FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029006FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029013FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029020FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029280FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029846FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029853FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029860FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029877FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029884FIREBIRD SFSOrthofix US LLCFSM2026-07-17