Amalgatome SD System (2" & 4") SDSYSTEM024

GUDID 00810006780093

Amalgatome SD System (2" & 4")

EXSURCO MEDICAL, INC.

Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic Dermatome handpiece, pneumatic
Primary Device ID00810006780093
NIH Device Record Keyc2d009c5-98ce-4ffa-b874-50e3708ed14c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmalgatome SD System (2" & 4")
Version Model NumberSDSYSTEM024
Catalog NumberSDSYSTEM024
Company DUNS079319210
Company NameEXSURCO MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Dimensions

Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch
Outer Diameter0 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100810006780093 [Primary]

FDA Product Code

GFDDermatome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


[00810006780093]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-20
Device Publish Date2021-01-12

Devices Manufactured by EXSURCO MEDICAL, INC.

00810006780123 - Mesh|Ex2024-03-28 Exsurco Mesher Kit
00810006780130 - Mesh|Ex 2024-03-28 ASM, Exsurco Mesher
00810006780147 - Mesh|Ex2024-03-28 ASM, Cutting Roller A
00810006780154 - Mesh|Ex2024-03-28 ASM, Feed Roller
00810006780161 - Mesh|Ex2024-03-28 Tray, Sterilization Mesher
00810006780185 - Mesh|Ex2024-03-28 ASM, Cutting Roller B
00810006780192 - Mesh|Ex2024-03-28 ASM, Cutting Roller C
00810006780215 - Mesh|Ex2024-03-28 ASM, Exsurco Mesher Base

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.