nvc
- Primary DI
- 00814008022861
- Company
- NVISION BIOMEDICAL TECHNOLOGIES, INC.
- Model
- AC-1416T-311
- Device description
- Instrument, Trial, Anterior Cervical Interbody Fusion System (ACIF)
- Published
- 2016-05-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 047486041
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
- true
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00814008022861 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00814008022861 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| MDM | Instrument, Manual, Surgical, General Use | 1 | General, Plastic Surgery | 878.4800 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Surgical tamp, reusable | A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device. |
Device Sizes
| Type | Value | Text |
|---|
| Angle | 6 degree | |
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| 210-545-3713 | diana@nvisionbiomed.com |
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