FDA.reportPublic FDA data

2-inch ASD Excision ring blade

Primary DI
10810006780083
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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 into a dermatome 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079319210
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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

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