FDA UDI
In Commercial Distribution
🇺🇸 United States
7.0mm Countersink, Cann, Hudson-Mod, 195mm
DI: 00816950027888
·
Model: 2004-0004
·
Osteocentric Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 7.0mm Countersink, Cann, Hudson-Mod, 195mm
- Primary DI
- 00816950027888
- Version / Model
- 2004-0004
- Catalog Number
- 2004-0004
- Company Name
- Osteocentric Technologies, Inc.
- Labeler DUNS
- 089645059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-17
- Public Version
- 3
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- aa9ad139-2307-4256-844d-d7201b8b3d02
Device Description
7.0mm Countersink, Cann, Hudson-Mod, 195mm
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWW | Countersink | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16462 | Surgical countersink, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816950027888 | GS1 |
Customer Contacts
- Phone
- 1800-969-0639
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170021 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 195 | Millimeter | |
| Outer Diameter | 7.0 | Millimeter |