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.

• 40677964048959 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, Defendo Fuji 4-piece Valves Kit, Absorbent
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• 40677964048997 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Flat Sponge, Defendo Fuji 5-piece Valves Kit, Absorbent Pad, Lu
• 40677964049147 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, 5-piece Olympus DCA Kit, Absorbent Pad, Lub
• 40677964049161 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, Defendo Pentax 4-piece Valves Kit, Absorben
• 40677964049253 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, 4-piece Olympus DCA Kit, Transport Pad and Lubricant.
• 40677964049277 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Transport Pad, Lubricant, Gauze, Gown and Biohazard Sticker.
• 40677964049291 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Flat Sponge, Defendo 4-piece Valves Kit, Drawstring Transport P