REDPINE

GUDID 06972520300875

Guangzhou Red Pine Medical Instrument Co., Ltd.

Flexible video ureterorenoscope, single-use

• Primary Device ID: 06972520300875
• NIH Device Record Key: bebd4478-39fe-48c8-9c0b-9c3356a37a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REDPINE
• Version Model Number: RP-U-C0304S3
• Company DUNS: 417649868
• Company Name: Guangzhou Red Pine Medical Instrument Co., 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972520300875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221158

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [REDPINE]

• 06972520300943: RP-U-P1502
• 06972520300936: RP-IPD-V800
• 06972520300912: RP-U-C0305S3
• 06972520300905: RP-U-C0305S9
• 06972520300899: RP-U-C0305R3
• 06972520300882: RP-U-C0305
• 06972520300875: RP-U-C0304S3
• 06972520300868: RP-U-C0304S9
• 06972520300851: RP-U-C0304R3
• 06972520300844: RP-U-C0304
• 06972520300837: RP-U-C12S3
• 06972520300820: RP-U-C12S9
• 06972520300813: RP-U-C12R3
• 06972520300806: RP-U-C12
• 06972520300776: RP-U-P1101
• 06972520300769: RP-U-P1302
• 06972520300752: RP-U-P0901
• 06972520300134: RP-U-C0305
• 06972520300066: RP-IPD-V800
• 06972520300011: RP-U-C12
• 06972520301407: RP-U-C01FS
• 06972520300622: RP-IPD-V2000EF
• 06972520300561: RP-U-C01F
• 06972520301018: RP-G-C0101
• 06972520301001: RP-G-C24
• 06972520301209: RP-IPD-V2000D
• 06972520301193: RP-IPD-V2000A
• 06972520301186: RP-IPD-V2000B
• 06972520301179: RP-IPD-V2000C
• 06972520301124: RP-GI-C02B
• 06972520301117: RP-GI-C02A
• 06972520301100: RP-GI-G02B
• 06972520301094: RP-GI-G02A
• 06972520300790: RP-U-C0201S
• 06972520300783: RP-U-C0201