Reprocessed Apollo RF Aspirating Ablator 90, Extra Large

GUDID B390AR98211

Apollo RF XL90, Aspirating Ablator 90°, Extra Large

SURETEK MEDICAL

Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed Arthroscopic shaver system blade, reprocessed

• Primary Device ID: B390AR98211
• NIH Device Record Key: de2549ee-55ed-496e-aa7b-d51baaa6cb0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Apollo RF Aspirating Ablator 90, Extra Large
• Version Model Number: AR-9821
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B390AR98211 [Primary]
HIBCC	B390AR98211 [Primary]
HIBCC	B390AR98211 [Primary]
HIBCC	B390AR98211 [Primary]
HIBCC	B390AR98211 [Primary]

FDA Product Code

• NBH: Accessories, Arthroscopic
• NBH: Accessories, Arthroscopic
• NBH: Accessories, Arthroscopic
• NBH: Accessories, Arthroscopic
• NBH: Accessories, Arthroscopic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-06
• Device Publish Date: 2020-10-29

Devices Manufactured by SURETEK MEDICAL

• B390AR98111 - Reprocessed Apollo RF Aspirating Ablator 90, Multi Port: 2020-11-06 Apollo RF MP90, Aspirating Ablator 90°, Multi-Port
• B390AR98211 - Reprocessed Apollo RF Aspirating Ablator 90, Extra Large: 2020-11-06 Apollo RF XL90, Aspirating Ablator 90°, Extra Large
• B390AR98211 - Reprocessed Apollo RF Aspirating Ablator 90, Extra Large: 2020-11-06 Apollo RF XL90, Aspirating Ablator 90°, Extra Large
• B3903859500081 - Reprocessed 5.5mm Round Bur, 8 Flute: 2020-11-05 5.5mm Beige/ Beige, Long Hip Round Bur, 8 Flute, XL
• B390S9247A1 - Reprocessed 4.2mm Full Radius Resector: 2020-11-05 4.3mm Yellow Carbon Coated, Full Radius Resector
• B390S9299A1 - Reprocessed 4.2mm Great White Blade Stealth: 2020-11-05 4.2mm Great White Blade, Carbon Coated Stealth
• B390S9399A1 - Reprocessed 3.5mm Great White Blade: 2020-11-05 3.5mm White, Great White Stealth
• B3902253011 - Reprocessed 3.5mm VAPR Side Effect Electrode: 2020-08-13 3.5mm VAPR Side Effect Electrode
• B3902253031 - Reprocessed 3.5mm VAPR Straight End Effect Electrode: 2020-08-13 Reprocessed 3.5mm VAPR Straight End Effect Electrode