FDA.reportPublic FDA data

Roadrunner

Primary DI
00827002464971
Brand
Roadrunner
Company
COOK INCORPORATED
Model
G46497
Catalog number
RPC-035145-01
Device description
Roadrunner Hydrophilic PC Wire Guide With 8cm Taper
Published
2018-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCYEndoscopic guidewire, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002464971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002464971008270024649718270024649710827002464971

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04262494460623N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460630N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494460647N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494462528N/ADoppkon GmbH & Co. KGOCY2025-09-12
04262494463969N/ADoppkon GmbH & Co. KGOCY2025-09-12
54953170465050VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465067VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465074VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465081VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465098VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465104VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465111VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465128VISIGLIDETERUMO CORPORATIONOCY2025-07-14
54953170465135VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465142VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465159VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465166VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465173VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465180VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465197VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
54953170465203VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767781SopranoColoplast A/SOCY2025-03-26
16932503510131Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510148Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510155Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16932503510162Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-11-01
16976055232974Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232981Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24
16976055232998Zebra Guidewire for Urinary TractSHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.OCY2024-04-24