FDA UDI
In Commercial Distribution
🇺🇸 United States
7.3mm Cannulated Screw, Short Threaded
DI: 06942782409005
·
Model: 060080075
·
Double Medical Technology Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 7.3mm Cannulated Screw, Short Threaded
- Primary DI
- 06942782409005
- Version / Model
- 060080075
- Catalog Number
- 060080075
- Company Name
- Double Medical Technology Inc.
- Labeler DUNS
- 529366055
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- 64fd51b9-b8f6-4b6a-a969-288c88c3cc4e
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
- Yes
- Has Expiration Date
- Yes
- 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 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58959 | Pin-sleeve orthopaedic bone screw | An implantable device comprising a small, threaded, cannulated sleeve containing a pin fixed inside at its distal end, intended to be used to hold a bone plate in place for internal orthopaedic fracture fixation. It is anchored to bone by the external thread on the sleeve and to the fixation plate by the thread on the head of the pin. It is intended to provide compression of the fracture site and to allow micro-movement for even distribution of load across the fixation plate to promote symmetrical callus formation. It is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)]. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06942782409005 | GS1 |
Customer Contacts
- Phone
- +865926087101
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130108 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Major diameter: 7.3mm | ||
| Device Size Text, specify | Minor diameter: 4.5mm | ||
| Length | 75.0 | Millimeter |