Ideal Eyes 0268000100

GUDID 07613327060454

HD Flexible Control Unit

STRYKER CORPORATION

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 07613327060454
• NIH Device Record Key: 356d65a4-8396-415a-a187-2361cbbed035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ideal Eyes
• Version Model Number: 0268000100
• Catalog Number: 0268000100
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327060454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121112

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23

On-Brand Devices [Ideal Eyes]

• 07613327062687: Stubby Arthroscope, Autoclavable, C-Mount, J-Lock, Reverse Cant, 30 ¿ View Direction
• 07613327062663: Stubby Arthroscope, Autoclavable, C-Mount, J-Lock, 30 Degree View Direction
• 07613327062410: HD Laparoscope, Autoclavable, 30 ¿ View Direction
• 07613327062403: HD Laparoscope, Autoclavable, 0 ¿ View Direction
• 07613327062366: Pediatric Scope, Autoclavable, 30 ¿ View Direction
• 07613327062359: Pediatric Scope, Autoclavable, 0 ¿ View Direction
• 07613327062342: Arthroscope, Autoclavable, J-Lock, Reverse Cant, 30 ¿ View Direction
• 07613327062335: Arthroscope, Autoclavable, J-Lock, 70 ¿ View Direction
• 07613327062328: Arthroscope, Autoclavable, J-Lock, 30 ¿ View Direction
• 07613327062311: Arthroscope, Autoclavable, J-Lock, 0 ¿ View Direction
• 07613327062304: Arthroscope, Autoclavable, J-Lock, 30 ¿ View Direction
• 07613327062298: Arthroscope, Autoclavable, J-Lock, 0 ¿ View Direction
• 07613327062250: HD Bariatric Articulating Laparoscope
• 07613327062243: HD Articulating Laparoscope
• 07613327062236: HD Articulating Laparoscope
• 07613327062106: Arthroscope, Autoclavable, J-Lock, 70 ¿ View Direction
• 07613327062090: Arthroscope, Autoclavable, J-Lock, 30 ¿ View Direction
• 07613327062076: Arthroscope, Autoclavable, J-Lock, 0 ¿ View Direction
• 07613327060454: HD Flexible Control Unit
• 07613327060294: Laparoscope, Autoclavable, Full Screen, 0 ¿ View Direction
• 07613327060287: Laparoscope, Autoclavable, Full Screen, 45 ¿ View Direction
• 07613327060263: HD IR Infrared Laparoscope, Autoclavable, 45 ¿ View Direction
• 07613327060201: HD IR Infrared Laparoscope, Autoclavable, 0 ¿ View Direction
• 07613327060188: HD IR Infrared Laparoscope, Autoclavable, 30 ¿ View Direction
• 07613327060171: Laparoscope, Autoclavable, Full Screen, 30 ¿ View Direction
• 07613327059823: Hysteroscope, Autoclavable, 12 ¿ View Direction
• 07613327059786: Hysteroscope, Autoclavable, 30 ¿ View Direction
• 07613327059748: Hysteroscope, Autoclavable, 0 ¿ View Direction
• 07613327059700: Arthroscope, Autoclavable, C-Mount, J-Lock, 30 ¿ View Direction
• 07613327059458: Laparoscope, Autoclavable, Full Screen, 45 ¿ View Direction
• 07613327059441: HD IR Infrared Laparoscope, Autoclavable, 45 ¿ View Direction
• 07613327059427: Laparoscope, Autoclavable, Full Screen, 30 ¿ View Direction
• 07613327059403: Laparoscope, Autoclavable, Full Screen, 0 ¿ View Direction
• 07613327059397: HD IR Infrared Laparoscope, Autoclavable, 30 ¿ View Direction
• 07613327059366: HD IR Infrared Laparoscope, Autoclavable, 0 ¿ View Direction
• 07613327053760: HD IR Bariatric Infrared Laparoscope, Autoclavable, Full Screen, 45 ¿ View Direction
• 07613327053753: HD IR Bariatric Infrared Laparoscope, Autoclavable, Full Screen, 30 ¿ View Direction
• 07613327053746: Bariatric Laparoscope, Autoclavable, 45 ¿ View Direction
• 07613327053722: Bariatric Laparoscope, Autoclavable, 30 ¿ View Direction
• 07613327053715: Bariatric Laparoscope, Autoclavable, 0 ¿ View Direction
• 07613327053708: HD IR Bariatric Infrared Laparoscope, Autoclavable, Full Screen, 30 ¿ View Direction
• 07613327053692: HD IR Bariatric Infrared Laparoscope, Autoclavable, Full Screen, 45 ¿ View Direction
• 07613327053685: HD IR Bariatric Infrared Laparoscope, Autoclavable, Full Screen, 0 ¿ View Direction
• 07613327053678: Bariatric Laparoscope, Autoclavable, 45 ¿ View Direction
• 07613327053654: Bariatric Laparoscope, Autoclavable, 30 ¿ View Direction
• 07613327053647: Bariatric Laparoscope, Autoclavable, 0 ¿ View Direction