FDA.reportPublic FDA data

REDPINE

Primary DI
06972520300783
Brand
REDPINE
Company
Guangzhou Red Pine Medical Instrument Co., Ltd.
Model
RP-U-C0201
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240663000Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-06-21FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972520300783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972520300783069725203007836972520300783

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. 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
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
00848657076135AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076142AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13