FDA UDI
In Commercial Distribution
🇺🇸 United States
Spirotome Spine
DI: 05407005001257
·
Model: SS08SP
·
Bioncise
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Spirotome Spine
- Primary DI
- 05407005001257
- Version / Model
- SS08SP
- Catalog Number
- SS08SP
- Company Name
- Bioncise
- Labeler DUNS
- 371402316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 1
- Public Version Date
- 2018-10-01
- Public Version Status
- New
- Public Device Record Key
- 88a9fa6b-8015-41ff-a635-937ee4fffba8
Device Description
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula - Injection needle • A release element This presentation has an external diameter of 8G (5 mm) and length of 150 mm.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 47540 | Soft-tissue biopsy needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05407005000250 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 05407005001257 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080095 | 000 |