4-inch ASD Excision ring blade X101788

GUDID 10810006780076

Amalgatome SD Surgical Skin Grafting and Debridement Blade

EXSURCO MEDICAL, INC.

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Primary Device ID10810006780076
NIH Device Record Keyb8aa5ed3-ea2d-4b04-a219-f7ea99c4f8c2
Commercial Distribution StatusIn Commercial Distribution
Brand Name4-inch ASD Excision ring blade
Version Model NumberX101788
Catalog NumberX101788
Company DUNS079319210
Company NameEXSURCO MEDICAL, INC.
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com
Phone800-243-6049
Emailsupport@exsurco.com

Device Dimensions

Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch
Outer Diameter4 Inch

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100810006780079 [Primary]
GS110810006780076 [Unit of Use]

FDA Product Code

GFDDermatome

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-26
Device Publish Date2021-02-18

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