Activa Instrument
- Primary DI
- 06438394010956
- Company
- Bioretec Oy
- Model
- B-IP-1502
- Catalog number
- B-IP-1502
- Device description
- K-wire Ø1.5 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs.
- Published
- 2026-03-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 368715301
- Device count
- 10
- DM exempt
- true
- 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 |
|---|
| E302BIP15029 | Previous | HIBCC | 0 | |
| 06438394010956 | Primary | GS1 | 0 | |
| 06438394020351 | Unit of Use | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| E302BIP15029 | Previous | HIBCC | 0 | | | | |
| 06438394010956 | Primary | GS1 | 0 | | | | |
| 06438394020351 | Unit of Use | 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 |
|---|
| Orthopaedic guidewire, reusable | A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device. |
Device Sizes
| Type | Value | Text |
|---|
| Length | 130 Millimeter | |
| Width | 1.5 Millimeter | |
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +358207789500 | sales@bioretec.com |
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