FDA UDI
In Commercial Distribution
🇺🇸 United States
Tranquil-C™
DI: B6788224680
·
Model: 822468
·
NEXUS SPINE, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tranquil-C™
- Primary DI
- B6788224680
- Version / Model
- 822468
- Company Name
- NEXUS SPINE, L.L.C.
- Labeler DUNS
- 028137605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-17
- Public Version
- 4
- Public Version Date
- 2024-07-10
- Public Version Status
- Update
- Public Device Record Key
- 2bbe96c6-abd8-4a7a-ad57-368ac8e2e00c
Device Description
Cervical Rasp +DS 5x12x12
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| HTR | Rasp | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35559 | Bone file/rasp, manual, reusable | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B6788224680 | HIBCC | ||||
| Direct Marking | B678822468 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 12 | Millimeter | |
| Length | 12 | Millimeter | |
| Height | 5 | Millimeter |