FDA.reportPublic FDA data

REDPINE

Primary DI
06972520300134
Brand
REDPINE
Company
Guangzhou Red Pine Medical Instrument Co., Ltd.
Model
RP-U-C0305
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221158000Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.2023-03-06FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972520300134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972520300134069725203001346972520300134

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureterorenoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
417649868
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972520300677Endoscopic Video Image ProcessorRP-IPD-V1000F2025-12-31
06972520301001REDPINERP-G-C242024-08-03
06972520301018REDPINERP-G-C01012024-08-03
06972520301216Ascend™ Single-Use Flexible UreteroscopeASUS-86-900R2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeASUS-86-300R2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeASUS-86-300S2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeASUS-86-900S2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeASUS-86-900R-DC2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeASUS-86-300R-DC2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeASUS-86-300S-DC2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeASUS-86-900S-DC2026-03-17
06972520301759Single-Use Video Flexible UreterorenoscopeRP-U-C03R92025-12-31
06972520301766Single-Use Video Flexible UreterorenoscopeRP-U-C03S92025-12-31
06972520301773Single-Use Video Flexible UreterorenoscopeRP-U-C03R32025-12-31
06972520301780Single-Use Video Flexible UreterorenoscopeRP-U-C03S32025-12-31
06972520302794Ascend™ Single-Use Flexible UreteroscopeASUS-75-900R2025-12-31
06972520302800Ascend™ Single-Use Flexible UreteroscopeASUS-75-900S2025-12-31
06972520302817Ascend™ Single-Use Flexible UreteroscopeASUS-75-300R2025-12-31
06972520302824Ascend™ Single-Use Flexible UreteroscopeASUS-75-300S2025-12-31
06972520302893Ascend™ Single-Use Flexible Cysto-Nephroscope HDASUS-HD-15R-CYS2025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140757WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140764WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140771WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140788WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140795AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140801AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06979988682000Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25
06979988682017Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25