F88 0503388008

GUDID 08881300750077

Pkg, Manual Leak Tester

SG ENDOSCOPY PTE. LTD.

Invasive medical device leak tester, mechanical

• Primary Device ID: 08881300750077
• NIH Device Record Key: 9f607d5b-d1be-4ca7-b90f-58cdaac91f0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F88
• Version Model Number: Pkg, Manual Leak Tester
• Catalog Number: 0503388008
• Company DUNS: 595455258
• Company Name: SG ENDOSCOPY PTE. LTD.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx
• Phone: (800) 624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	08881300750077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243894

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-08
• Device Publish Date: 2025-06-30

On-Brand Devices [F88]

• 08881300750152: Flexible Camera Control Unit
• 08881300750046: Pkg, Luer Lock Stopcock, Reusable, Female X Male
• 08881300750091: Flexible Ureteroscope, Reverse Deflection
• 08881300750084: Flexible Ureteroscope, Standard Deflection
• 08881300750077: Pkg, Manual Leak Tester
• 08881300750060: Pkg, Venting Valve Cap With Sterilization Card