FDA UDI
In Commercial Distribution
🇺🇸 United States
OsteoMed
DI: 00845694041577
·
Model: 320-2727
·
OSTEOMED LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OsteoMed
- Primary DI
- 00845694041577
- Version / Model
- 320-2727
- Catalog Number
- 320-2727
- Company Name
- OSTEOMED LLC
- Labeler DUNS
- 606417780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-21
- Public Version
- 3
- Public Version Date
- 2020-01-28
- Public Version Status
- Update
- Public Device Record Key
- 6ca622de-e9c9-4814-96f0-f358a3c3ca34
Device Description
2.7mm Countersink, Quick Release
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HRS | Plate, fixation, bone | Orthopedic | 888.3030 | 2 |
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 | 00845694041577 | GS1 |
Customer Contacts
- Phone
- +1(800)456-7779 ext. 1
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at controlled room temperatureand used in a sterile environment.
- Type
- Handling Environment Temperature
- Temperature Range
- High: 275 Degrees Fahrenheit