GEM BiPolar Jewelers Forceps 521440250010

GUDID 00844735006049

Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Primary Device ID00844735006049
NIH Device Record Key334648e6-af69-479e-8214-88f988a31359
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM BiPolar Jewelers Forceps
Version Model NumberGEM4025J-NS-S
Catalog Number521440250010
Company DUNS031284586
Company NameSYNOVIS MICRO COMPANIES ALLIANCE, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100844735006049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


[00844735006049]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [GEM BiPolar Jewelers Forceps]

00844735006056Reusable bipolar forceps designed to function as active electrodes or as accessories to active e
00844735006049Reusable bipolar forceps designed to function as active electrodes or as accessories to active e

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