FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04546540169594
·
Model: 0298097100
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04546540169594
- Version / Model
- 0298097100
- Catalog Number
- 0298-097-100
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-23
- Public Version
- 4
- Public Version Date
- 2022-02-14
- Public Version Status
- Update
- Public Device Record Key
- 3489e1ef-8ecf-44fd-a19d-6f335ca69f88
Device Description
Sternum Blade, Offset (32.0 x 0.8 x 6.3mm)
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
- Yes
- 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 |
|---|---|---|---|---|
| DWH | BLADE, SAW, SURGICAL, CARDIOVASCULAR | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44632 | Sternum saw blade, single-use | A flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc-shaped) and is powered by a rapid reciprocating, oscillating or sagittal motion provided by the saw. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04546540169594 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 6.3 | Millimeter | |
| Device Size Text, specify | Material Thickness: 0.8 Millimeter | ||
| Device Size Text, specify | Cut Edge: 32.0 Millimeter | ||
| Device Size Text, specify | Cut Thickness: 1.02 Millimeter |