FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
DI: 05055662930825
·
Model: OS200025LC
·
ORTHO SOLUTIONS HOLDINGS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHO SOLUTIONS ULTOS PLATING SYSTEM
- Primary DI
- 05055662930825
- Version / Model
- OS200025LC
- Catalog Number
- OS200025LC
- Company Name
- ORTHO SOLUTIONS HOLDINGS LIMITED
- Labeler DUNS
- 218648211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-24
- Public Version
- 4
- Public Version Date
- 2018-11-22
- Public Version Status
- Update
- Public Device Record Key
- 706b0989-8ad0-4331-a4d5-67f0ddfcd258
Device Description
DRILL BIT 2.5MM X 143MM CALIBRATED
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47563 | Fluted surgical drill bit, single-use, non-sterile | A non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055662930818 | GS1 | Cardboard Box | 10 | In Commercial Distribution | |
| Primary | 05055662930825 | GS1 |
Customer Contacts
- Phone
- +441621843599
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141784 | 000 |