FDA.reportPublic FDA data

Bulldog

Primary DI
00827002465428
Brand
Bulldog
Company
Cook Vandergrift Inc.
Model
G46542
Catalog number
LR-LED01
Device description
Bulldog Lead Extender
Published
2023-07-06
Public version status
New
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002465428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002465428008270024654288270024654280827002465428

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead extraction extenderA device intended to be used during the release and removal of a cut implantable pacemaker or implantable cardioverter-defibrillator (ICD) lead, of the solid type (lumenless), from surrounding tissue during lead extraction. It is a sterile wire with a loop and self-locking mechanism (e.g., a bulldog clamp) at the distal end which is attached to the end of the lead. After it has been secured to the lead, the surgeon can pull on it and apply tension to the lead whilst a sheath or similar type tissue removal tool is advanced down the device and over the lead to free the lead from adherent tissue. 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
056867526
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
00827002260573Cook FlexipetG26057K-FPIP-1600-10BS-52016-09-24
00827002267114Cook FlexipetG26711K-FPIP-1130-10BS-52016-09-24
00827002267121Cook FlexipetG26712K-FPIP-1140-10BS-52016-09-24
00827002267138Cook FlexipetG26713K-FPIP-1170-10BS-52016-09-24
00827002327955CookG32795K-EBPH-30352016-09-24
00827002327993CookG32799K-EBPH-35352016-09-24
00827002460171Cook FlexipetG46017K-FPIP-1300-102016-09-24
00827002460188Cook FlexipetG46018K-FPIP-1170-102016-09-24
00827002460195Cook FlexipetG46019K-FPIP-1140-102016-09-24
00827002460201Cook FlexipetG46020K-FPIP-1300-10BS-52016-09-24
00827002460218Cook FlexipetG46021K-FPIP-1120-10BS-52016-09-24
10827002188782Cook FlexipetG18878K-FPIP-1300-10BS2016-09-24
10827002261812Cook FlexipetG26181K-FPIP-1080-10BS2016-09-24
10827002267180Cook FlexipetG26718K-FPIP-1100-10BS2016-09-24
00827002609891COOKG60989K-EBPH-20302025-07-24
00827002610132COOKG61013K-EBPH-20352025-07-24
00827002610149COOKG61014K-EBPH-25302025-07-24
00827002610156COOKG61015K-EBPH-25352025-07-24
10827002609898COOKG60989K-EBPH-20302025-07-24
10827002610139COOKG61013K-EBPH-20352025-07-24

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Primary DI, Brand, Company table
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