FDA.reportPublic FDA data

Amalgatome SD Hand Piece (Drive Unit)

Primary DI
00810006780017
Brand
Amalgatome SD Hand Piece (Drive Unit)
Company
EXSURCO MEDICAL, INC.
Model
X101016
Catalog number
X101016
Device description
Drive Unit ASD
Published
2021-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFDDermatome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFDDermatomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810006780017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006780017008100067800178100067800170810006780017

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome, pneumaticA pneumatically-powered surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade. This instrument will typically be driven by compressed gas [e.g., surgical-grade air, nitrogen (N2)] from a medical gas supply system. 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
Premarket exempt
true
Lot or batch
true
Serial number
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
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
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
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05055445901202SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901219SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901226SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05056111338759SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
09348811000262INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000293INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000316INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
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06975808860160MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
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