FDA UDI
In Commercial Distribution
🇺🇸 United States
icotec Systems, Saw blade
DI: 07640172553909
·
Model: 42-891
·
icotec AG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- icotec Systems, Saw blade
- Primary DI
- 07640172553909
- Version / Model
- 42-891
- Catalog Number
- 42-891
- Company Name
- icotec AG
- Labeler DUNS
- 480789465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 2
- Public Version Date
- 2025-11-18
- Public Version Status
- Update
- Public Device Record Key
- cd911523-3983-4bae-a828-439be91b3975
Device Description
icotec Systems, Saw blade
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | 888.3027 | 2 |
| NKG | Posterior Cervical Screw System | Orthopedic | 888.3075 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44983 | Manual surgical saw blade, rigid | A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a rigid manual hand saw used for cutting bone/tissue when a directional pressure is applied. This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is manually powered in a back and forth motion by the user. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640172553909 | GS1 |
Customer Contacts
- Phone
- +41717570000
- [email protected]