FDA UDI
In Commercial Distribution
🇺🇸 United States
Bone Acess Needle
DI: B183FSDBANJ0806TL0
·
Model: FS-DBANJ0806TL
·
FLOSPINE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bone Acess Needle
- Primary DI
- B183FSDBANJ0806TL0
- Version / Model
- FS-DBANJ0806TL
- Catalog Number
- FS-DBANJ0806TL
- Company Name
- FLOSPINE LLC
- Labeler DUNS
- 042993143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-04
- Public Version
- 1
- Public Version Date
- 2025-04-14
- Public Version Status
- New
- Public Device Record Key
- 8cf4ef9b-8542-4894-822c-b20cc669c928
Device Description
Bone Acess Needle 8ga x 6in
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
- No
- 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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60478 | Bone access cannula | A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B183FSDBANJ0806TL0 | HIBCC |
Customer Contacts
- Phone
- (561)705-3080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141850 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8ga x 6in |