CrossTIE™ Reamer 3.0mm
- Primary DI
- 00850310006465
- Brand
- CrossTIE™ Reamer 3.0mm
- Company
- CROSSROADS EXTREMITY SYSTEMS
- Model
- 1400-1030
- Catalog number
- 1400-1030
- Device description
- Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
- Published
- 2023-01-05
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HTO | Reamer |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HTO | Reamer | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850310006465 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850310006465 | 00850310006465 | 850310006465 | 0850310006465 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic inorganic implant inserter/extractor, reusable | A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device. |
Regulatory Flags#
- DUNS number
- 058864308
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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