Reprocessed Apollo RF Aspirating Ablator 90, Multi Port

GUDID B390AR98111

Apollo RF MP90, Aspirating Ablator 90°, Multi-Port

SURETEK MEDICAL

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Primary Device IDB390AR98111
NIH Device Record Keyb2afdc77-9e40-4e54-8b5e-5656346b603a
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Apollo RF Aspirating Ablator 90, Multi Port
Version Model NumberAR-9811
Company DUNS785616934
Company NameSURETEK MEDICAL
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB390AR98111 [Primary]
HIBCCB390AR98111 [Primary]
HIBCCB390AR98111 [Primary]
HIBCCB390AR98111 [Primary]
HIBCCB390AR98111 [Primary]

FDA Product Code

NBHAccessories, Arthroscopic
NBHAccessories, Arthroscopic
NBHAccessories, Arthroscopic
NBHAccessories, Arthroscopic
NBHAccessories, Arthroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-06
Device Publish Date2020-10-29

Devices Manufactured by SURETEK MEDICAL

B390AR98111 - Reprocessed Apollo RF Aspirating Ablator 90, Multi Port2020-11-06Apollo RF MP90, Aspirating Ablator 90°, Multi-Port
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B390AR98211 - Reprocessed Apollo RF Aspirating Ablator 90, Extra Large2020-11-06 Apollo RF XL90, Aspirating Ablator 90°, Extra Large
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B390S9299A1 - Reprocessed 4.2mm Great White Blade Stealth2020-11-05 4.2mm Great White Blade, Carbon Coated Stealth
B390S9399A1 - Reprocessed 3.5mm Great White Blade2020-11-05 3.5mm White, Great White Stealth
B3902253011 - Reprocessed 3.5mm VAPR Side Effect Electrode2020-08-13 3.5mm VAPR Side Effect Electrode
B3902253031 - Reprocessed 3.5mm VAPR Straight End Effect Electrode2020-08-13 Reprocessed 3.5mm VAPR Straight End Effect Electrode

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