Scope Buddy Plus

GUDID 00677964073755

MEDIVATORS INC.

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• Primary Device ID: 00677964073755
• NIH Device Record Key: b39595b1-7b96-4c33-b72c-84f5a98cb6b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scope Buddy Plus
• Version Model Number: SPB-1000
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	00677964073755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162128

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-16

Devices Manufactured by MEDIVATORS INC.

• 40677964045675 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Defendo Fuji 4-piece Valve Kit, Lubricant and Gauze.
• 40677964045699 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Flat Sponge, Bioshield Biopsy Valve, Drawstring Transport Pad, Absorbent Pad, Lubric
• 40677964045712 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Dry Sponge, Absorbent Pad, Suction Tube, Gown, Nasal Cannula, ECG Electrode and Suct
• 40677964045736 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Revital-Ox Bedside Concentrate, Defendo-Fuji 4-piece Valve Kit, Transport Pad, Lubri
• 40677964045750 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Bioshield Biopsy Valve, Transport Pad, Lubricant, Gauze, Double He
• 40677964045774 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Clyllindrical Sponge, 5-piece Olympus DCA Kit, Drawstring Trans
• 40677964045798 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Absorbent Pad and Water Label.
• 40677964045811 - Endo Carry-on Procedure Kit: 2024-04-12 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Drawstring Transport Pad, Lubricant, Gauz