FDA.reportPublic FDA data

Wholey™

Primary DI
20763000185804
Brand
Wholey™
Company
Covidien LP
Model
WWES35001
Device description
GW WWES35001 WHOLEY WIRE V04
Published
2020-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, guide, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120863000WHOLEY GUIDE WIRE SYSTEMCovidien, LLC2012-04-19DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000185804PackageGS13In Commercial Distribution
00763000185800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300018580420763000185804
00763000185800007630001858007630001858000763000185800

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire extensionA long, thin, sterile wire designed to provide the necessary length to allow the exchange of a catheter, or other interventional device, while maintaining the intravascular position of the catheter guidewire during an interventional procedure in the peripheral vasculature. It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and is supplied with a connector (e.g., self-locking taper) to facilitate its joining to the proximal end of the in situ guidewire to create the extension (e.g., 150 mm). After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter0.089Centimeter
Guidewire Length155Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the guidewire away from sunlight at room temperature in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
968903703
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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