FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04546540531810
·
Model: 5290760100
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04546540531810
- Version / Model
- 5290760100
- Catalog Number
- 5290-760-100
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- fae87b72-ab2e-4811-99f3-5f3b61b5b1bb
Device Description
4.0 mm ENT Precision Cutter Angle Agg. 60 Degree ESSx/HUMMER 4 11.0 cm Working Length
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 |
|---|---|---|---|---|
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43376 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34546540531811 | GS1 | pack | 5 | In Commercial Distribution | |
| Primary | 04546540531810 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 60.0 | degree | |
| Length | 11.0 | Centimeter | |
| Device Size Text, specify | Diameter: 4.0 Millimeter |