FDA.reportPublic FDA data

2-inch ASD Excision ring blade

Primary DI
00810006780086
Brand
2-inch ASD Excision ring blade
Company
EXSURCO MEDICAL, INC.
Model
X101789
Catalog number
X101789
Device description
Amalgatome SD Surgical Skin Grafting and Debridement Blade
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00810006780086PrimaryGS10
10810006780083Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006780086008100067800868100067800860810006780086
1081000678008310810006780083

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome blade, single-useA surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity

Contacts#

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

Regulatory Flags#

DUNS number
079319210
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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

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