Sunmed guidewire torque device

Primary DI
06947358544302
Brand
Sunmed guidewire torque device
Company
Sunny Medical Device (Shenzhen) Co., Ltd.
Model
plastic type, white
Published
2022-01-04
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
PTLWire, Guide, Catheter, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTLWire, Guide, Catheter, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947358544302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947358544302069473585443026947358544302

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529639795
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#

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06947358535713Sunmed Guide WiresJ tip, 0.035in, 150cm2021-12-13
06947358535751Sunmed Guide WiresS tip, 0.035in, 150cm2021-12-13
06947358535812Sunmed Guide WiresJ tip, 0.035in, 260cm2021-12-13
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06947358520405Sunmed High Pressure Line400psi, 15cm2020-04-15
06947358551904Sunmed Manifold and Stopcocks500psi, off hand2020-04-15
06947358563006Sunmed Inflation Device30atm, 30ml2020-04-15
06947358500001Sunmed Protective face shield340mm×220mm2020-08-22
06947358516019AirTight Control Syringes10ml2019-09-04

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