FDA UDI
In Commercial Distribution
🇺🇸 United States
Bulldog
DI: 00827002465428
·
Model: G46542
·
Cook Vandergrift Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bulldog
- Primary DI
- 00827002465428
- Version / Model
- G46542
- Catalog Number
- LR-LED01
- Company Name
- Cook Vandergrift Inc.
- Labeler DUNS
- 056867526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 1
- Public Version Date
- 2023-07-14
- Public Version Status
- New
- Public Device Record Key
- 1c9e6f07-c63e-4328-b987-ea537121c3f8
Device Description
Bulldog Lead Extender
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47024 | Pacing/defibrillation lead extraction extender | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002465428 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.