FDA UDI
In Commercial Distribution
🇺🇸 United States
Geomax Reamer Set
DI: 07649990202396
·
Model: 1
·
Surgical Fusion Technologies GmbH
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Geomax Reamer Set
- Primary DI
- 07649990202396
- Version / Model
- 1
- Catalog Number
- T04-004
- Company Name
- Surgical Fusion Technologies GmbH
- Labeler DUNS
- 482948937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-01
- Public Version
- 1
- Public Version Date
- 2025-10-09
- Public Version Status
- New
- Public Device Record Key
- 1349baec-8325-46a7-9a62-7365c9cf2813
Device Description
Tray for Geomax Reamer S-PI-Axx and Handle S, for SF Push-in Anchor Portfolio
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
- 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
- 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 |
|---|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | 888.3030 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
| HTY | Pin, Fixation, Smooth | Orthopedic | 888.3040 | 2 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07649990202396 | GS1 |
Customer Contacts
- Phone
- +41442046018
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240288 | 000 |