FDA UDI
In Commercial Distribution
🇺🇸 United States
Nova
DI: 00385480388467
·
Model: Nova
·
NOVA BIOMEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
Basic Information
- Brand Name
- Nova
- Primary DI
- 00385480388467
- Version / Model
- Nova
- Catalog Number
- 38846
- Company Name
- NOVA BIOMEDICAL CORPORATION
- Labeler DUNS
- 070617139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 306327c0-387d-408b-956c-518062f03c2b
Device Description
Nova Biomedical® Capillary Tube Clot Catcher
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62624 | Surgical traction tensioner connector | A connecting/extension device intended to be fastened between a surgical traction tensioner/rod/cord and a patient-contact traction device (e.g., orthopaedic bone wire, foot boot, hand wrap/trap) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis). It is intended to be used during a surgical procedure (e.g., fracture reduction, pelvic reconstruction); some types may in addition be used in an orthopaedic bed over a period typically to promote reduction/healing of a fracture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00385489388468 | GS1 | ||||
| Primary | 00385480388467 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius