FDA UDI
In Commercial Distribution
🇺🇸 United States
Monster® Screw System
DI: 00889795022752
·
Model: P25-910-6200
·
Paragon 28, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Monster® Screw System
- Primary DI
- 00889795022752
- Version / Model
- P25-910-6200
- Catalog Number
- P25-910-6200
- Company Name
- Paragon 28, Inc.
- Labeler DUNS
- 042961576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 3
- Public Version Date
- 2025-11-19
- Public Version Status
- Update
- Public Device Record Key
- 8df54850-44b8-447d-918b-ea0829a3df93
Device Description
Countersink, Ø6.2mm, Headed, SS
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
- 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 |
|---|---|---|---|---|
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 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 | 00889795022752 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190586 | 000 |