FDA.reportPublic FDA data

Wholey™

Primary DI
20763000919621
Brand
Wholey™
Company
EV3, INC
Model
WWSS35300
Device description
GW WWSS35300 WHOLEY WIRE STND STR 300CM
Published
2024-06-01
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
20763000919621PackageGS13In Commercial Distribution
00763000919627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300091962120763000919621
00763000919627007630009196277630009196270763000919627

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter0.089Centimeter
Guidewire Length300Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117446916
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
00199150028399Liberant™LMT-TRX2026-05-07
00821684071397Protégé™ GPS™SERB65-09-20-1202015-09-04
00821684071403Protégé™ GPS™SERB65-09-20-802015-09-04
00821684071410Protégé™ GPS™SERB65-09-30-1202015-09-04
00821684071427Protégé™ GPS™SERB65-09-30-802015-09-04
00821684071434Protégé™ GPS™SERB65-09-40-1202015-09-04
00821684071441Protégé™ GPS™SERB65-09-40-802015-09-04
00821684071458Protégé™ GPS™SERB65-09-60-1202015-09-04
00821684071465Protégé™ GPS™SERB65-09-60-802015-09-04
00821684071472Protégé™ GPS™SERB65-09-80-1202015-09-04
00821684071489Protégé™ GPS™SERB65-09-80-802015-09-04
00821684071496Protégé™ GPS™SERB65-10-20-1202015-09-01
00821684071502Protégé™ GPS™SERB65-10-20-802015-09-01
00821684071519Protégé™ GPS™SERB65-10-30-1202015-09-01
00821684071526Protégé™ GPS™SERB65-10-30-802015-09-01
00821684071533Protégé™ GPS™SERB65-10-40-1202015-09-01
00821684071540Protégé™ GPS™SERB65-10-40-802015-09-01
00821684071557Protégé™ GPS™SERB65-10-60-1202015-09-01
00821684071564Protégé™ GPS™SERB65-10-60-802015-09-01
00821684071571Protégé™ GPS™SERB65-10-80-1202015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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