DISPOCAP

GUDID 04961333241767

PENTAX DISPOCAP AIR, 10/PKG

PENTAX OF AMERICA, INC.

Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04961333241767
• NIH Device Record Key: b43cd098-a172-418f-9c1f-bcf5b5ce58fe
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DISPOCAP
• Version Model Number: 100160P
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• 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: false
• 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	04961333241767 [Primary]
GS1	14961333241764 [Unit of Use]

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: 2018-10-08
• Device Publish Date: 2018-03-13

On-Brand Devices [DISPOCAP]

• 04961333241767: PENTAX DISPOCAP AIR, 10/PKG
• 04961333241750: PENTAX DISPOCAP CO2, 10/PKG