N/A

GUDID 14961333221612

PROfILE Single Use Endoscope Cleaning Brush Kits

HOYA CORPORATION

Surgical instrument/endoscope cleaning brush/tool, single-use Surgical instrument/endoscope cleaning brush/tool, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use

• Primary Device ID: 14961333221612
• NIH Device Record Key: 708ff6b7-fe68-47c5-b948-37c325e8f800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: CS4010A
• Company DUNS: 691519705
• Company Name: HOYA CORPORATION
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	04961333221615 [Unit of Use]
GS1	14961333221612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172156

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)
• MNL: Accessories, Cleaning Brushes, 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: 2019-10-07
• Device Publish Date: 2019-01-15

On-Brand Devices [N/A]

• 14961333221650: PROfILE Single Use Endoscope Cleaning Brush Kits
• 14961333221612: PROfILE Single Use Endoscope Cleaning Brush Kits
• 14961333221438: PENTAX Medical single use suction control valve
• 04961333233007: ED34-i10T2
• 04961333234066: EC34-i10TL
• 04961333233991: EG34-i10
• 04961333222162: EB19-J10U
• 04961333239634: PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U
• 04961333239535: PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR
• 04961333239436: PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT
• 04961333221530: PENTAX Medical Video Bronchoscope EB19-J10
• 04961333221486: PENTAX Medical Video Bronchoscope EB15-J10
• 04961333248292: Made in Malaysia
• 04961333248186: Made in Malaysia
• 04961333248155: Made in Malaysia
• 04961333248124: Made in Malaysia
• 04961333248988: PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia)
• 04961333248902: PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia)
• 04961333248827: PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia)
• 04961333245802: PENTAX Medical Video Bronchoscope EB11-J10
• 04961333245987: PENTAX Medical Video Upper GI Scope EG17-J10
• 04961333251315: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU)
• 04961333251148: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Electronic IFU)
• 04961333221417: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU)
• 04961333221370: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Electronic IFU)
• 04961333221325: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU)
• 04961333246168: PENTAX Medical Video Duodenoscope ED32-i10
• 04961333251575: PENTAX Medical Video Bronchoscope EB11-J10 (Made in Malaysia)
• 04961333251490: PENTAX Medical Video Bronchoscope EB19-J10 (Made in Malaysia)
• 04961333251223: "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Electronic IFU)