N/A
- Primary DI
- 00817438028595
- Company
- Omega Surgical Instruments Inc
- Model
- SM-3058
- Device description
- 30.0 MM X 5.8 MM X 0.61 MM SAGITTAL BLADE
- Published
- 2025-07-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 808825038
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- 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 |
|---|
| 00817438028595 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00817438028595 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | General, Plastic Surgery | 878.4820 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Surgical saw blade, sagittal, single-use | A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Contacts
| Phone | Email |
|---|
| 8106959800 | complaints@omegasurgical.com |
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| 00887919258568 | Large Bone Blade | Peter Brasseler Holdings, LLC | GFA | 2025-11-26 |