FDA.reportPublic FDA data

REDPINE

Primary DI
06972520301117
Brand
REDPINE
Company
Guangzhou Red Pine Medical Instrument Co., Ltd.
Model
RP-GI-C02A
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232043000Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-02-16FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972520301117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972520301117069725203011176972520301117

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. 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
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920325PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920660PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921230PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921278PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921353PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921865PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921940PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921957PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25