FDA UDI
In Commercial Distribution
🇺🇸 United States
Thoratec® HeartMate 3™ Surgical Hand Tools
DI: 00813024013259
·
Model: 10002222US
·
Thoratec Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thoratec® HeartMate 3™ Surgical Hand Tools
- Primary DI
- 00813024013259
- Version / Model
- 10002222US
- Catalog Number
- 10002222US
- Company Name
- Thoratec Corporation
- Labeler DUNS
- 070156955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-30
- Public Version
- 6
- Public Version Date
- 2019-06-20
- Public Version Status
- Update
- Public Device Record Key
- 93a8fa37-e937-4ed9-9b5a-4600820c69da
Device Description
HM3 Surgical Hand Tools
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSQ | Ventricular (Assisst) Bypass | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46409 | Cardiothoracic surgical procedure kit, non-medicated, reusable | A collection of various sterile cardiothoracic surgical instruments dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This device is reusable after appropriate cleaning/sterilization of the instruments/reusable products, and when the consumable/pharmaceutical products have been replenished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813024013259 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius