FDA.reportPublic FDA data

RADIFOCUS

Primary DI
36927675513480
Brand
RADIFOCUS
Company
Terumo Medical Products (Hangzhou) Co., Ltd.
Model
XX*RF02AH
Catalog number
TD01
Device description
Torque Device
Published
2022-12-08
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
MOFGuide, Wire, Catheter, Neurovasculature
PTLWire, Guide, Catheter, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2
PTLWire, Guide, Catheter, ExemptCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220934000RADIFOCUS Torque DeviceTerumo Medical Products (Hangzhou) Co., Ltd.2022-06-29MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
56927675513484PackageGS14In Commercial Distribution
76927675513488PackageGS120In Commercial Distribution
36927675513480PrimaryGS10
06927675513489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5692767551348456927675513484
7692767551348876927675513488
3692767551348036927675513480
06927675513489069276755134896927675513489

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT.

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
544830912
Device count
5
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36927675520433SURFLO MIDELAMCSD001FMCSD001F2026-04-01
36927675517273SURFLO MIDELAMCS1810D01FMCS1810D01F2026-04-01
36927675517280SURFLO MIDELAMCS2010D00FMCS2010D00F2026-04-01
36927675517297SURFLO MIDELAMCS2208D01FMCS2208D01F2026-04-01
36927675517303SURFLO MIDELAMCS1810D00FMCS1810D00F2026-04-01
36927675517310SURFLO MIDELAMCS2208D00FMCS2208D00F2026-04-01
36927675519857SURFLO MIDELAMCS1808D00FMCS1808D00F2026-04-01
36927675519864SURFLO MIDELAMCS2008D00FMCS2008D00F2026-04-01
36927675520457SURFLO HYBRIASH18322332AFSH18322332AF2026-04-01
36927675520464SURFLO HYBRIASH18252332AFSH18252332AF2026-04-01
36927675520471SURFLO HYBRIASH20322332AFSH20322332AF2026-04-01
36927675520488SURFLO HYBRIASH20252332AFSH20252332AF2026-04-01
36927675520495SURFLO HYBRIASH22252332AFSH22252332AF2026-04-01
36927675520501SURFLO HYBRIASH22192332AFSH22192332AF2026-04-01
36927675520518SURFLO HYBRIASH24192332AFSH24192332AF2026-04-01
36927675520525SURFLO HYBRIASH18322320AFSH18322320AF2026-04-01
36927675520532SURFLO HYBRIASH18252320AFSH18252320AFF2026-04-01
36927675520549SURFLO HYBRIASH20322320AFSH20322320AF2026-04-01
36927675520556SURFLO HYBRIASH20252320AFSH20252320AF2026-04-01
36927675520563SURFLO HYBRIASH22252320AFSH22252320AF2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547327159517CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
04547327159524CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
04547327159531CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
00850076777326Willow 18 GuidewireArbor Endovascular LLCMOF2026-03-16
00850076777333Willow 18 GuidewireArbor Endovascular LLCMOF2026-03-16
00850076777401Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777418Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777425Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777432Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777449Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777456Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777463Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777470Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777487Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SAMOF2026-03-02
00850076777203Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777210Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777227Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777234Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777241Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777258Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777265Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777272Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777289Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777296Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777302Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777319Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777029Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-01
00850076777005Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28
00850076777012Willow 14 GuidewireArbor Endovascular LLCMOF2025-11-28