ENDO SMARTCAP

GUDID 00677964059575

MEDIVATORS INC.

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 00677964059575
• NIH Device Record Key: 648435ac-28a8-4ae0-926a-268d9dcd775f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDO SMARTCAP
• Version Model Number: 100165CO2
• 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: 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
GS1	00677964059575 [Primary]
GS1	10677964059572 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	20677964059579 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093665

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-15
• Device Publish Date: 2016-09-22

On-Brand Devices [ENDO SMARTCAP]

• 00677964059605: 100551
• 00677964059599: 100165
• 00677964059575: 100165CO2
• 00677964059551: 100160
• 00677964059537: 100150
• 00677964059506: 100150CO2
• 00677964059490: 100145
• 00677964059469: 100145CO2
• 00677964059452: 100141
• 00677964059124: 100165CO2EXT
• 00677964059100: 100150CO2EXT
• 00677964059087: 100145CO2EXT
• 00677964057328: 100555
• 40677964013766: 100164CO2U
• 40677964013780: 100164CO2EXT
• 40677964013742: 100164CO2
• 40677964013728: 100164U
• 40677964013803: 100164CO2EXTU
• 40677964013704: 100164
• 00724995219277: ENDO SMARTCAP Kit for FUJIFILM 700 Series GI Endoscopes for CO2 Connection with ENDO STRATUS
• 00724995219260: ENDO SMARTCAP Kit for FUJIFILM GI Endoscopes for CO2 Connection with ENDO STRATUS
• 00724995219253: ENDO SMARTCAP Kit for certain Olympus and Pentax GI Endoscopes for CO2 Connection with ENDO STR
• 00724995219246: ENDO SMARTCAP Kit for certain Olympus GI Endoscopes with connection to ENDO STRATUS
• 20677964074930: Disposable Tubing- for Pentax GI Endoscopes Air to CO2 Adapter