FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHO SOLUTIONS STERILE DRILL BITS
DI: 05055662932928
·
Model: OS319050
·
ORTHO SOLUTIONS HOLDINGS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHO SOLUTIONS STERILE DRILL BITS
- Primary DI
- 05055662932928
- Version / Model
- OS319050
- Catalog Number
- OS319050
- Company Name
- ORTHO SOLUTIONS HOLDINGS LIMITED
- Labeler DUNS
- 218648211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 46306e82-ff5a-4724-9b61-99ac5291eb01
Device Description
2.3MM PHALANGEAL SCREW COUNTERSINK
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 |
|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47634 | Surgical countersink, single-use | A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055662932911 | GS1 | Cardboard Box | 10 | In Commercial Distribution | |
| Primary | 05055662932928 | GS1 |
Customer Contacts
- Phone
- +441621843599
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102743 | 000 |