FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cross-Fuse® PEEK IBF System
DI: 00191083033716
·
Model: 35-INSERTER-18
·
Pioneer Surgical Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cross-Fuse® PEEK IBF System
- Primary DI
- 00191083033716
- Version / Model
- 35-INSERTER-18
- Catalog Number
- 35-INSERTER-18
- Company Name
- Pioneer Surgical Technology, Inc.
- Labeler DUNS
- 793384496
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-17
- Public Version
- 3
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- f8b866d8-8f0e-45ca-898e-2f0a3a27f422
- Distribution End Date
- 2023-02-10
Device Description
INSERTER
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic manual surgical instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12696 | Orthopaedic implant inserter/extractor, reusable | A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191083033716 | GS1 | ||||
| Previous | 00846468038755 | GS1 |
Customer Contacts
- Phone
- +1(906)226-9909
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 18mm |