Monopolar scissors

GUDID 24714127868466

UNIMAX MEDICAL SYSTEMS INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID24714127868466
NIH Device Record Keye21cd0f6-72e4-4ce6-850b-ddfaf343a31e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonopolar scissors
Version Model NumberFMS333057
Company DUNS658122465
Company NameUNIMAX MEDICAL SYSTEMS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Dimensions

Length33 Centimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter
Outer Diameter5 Millimeter
Length33 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104714127868462 [Primary]
GS114714127868469 [Package]
Contains: 04714127868462
Package: Box [10 Units]
In Commercial Distribution
GS124714127868466 [Package]
Contains: 14714127868469
Package: Carton [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-17
Device Publish Date2019-01-22

On-Brand Devices [Monopolar scissors]

24714127868466FMS333057
24714127867124FMS333054
24714127865984FMS333050
24714127862990FMS433055
04714127862989FMS445055
24714127862976FMS433056

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