FDA UDI
In Commercial Distribution
🇺🇸 United States
Dyna Locking Ankle Nail™
DI: 08800015913638
·
Model: NA1016
·
CG MedTech Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dyna Locking Ankle Nail™
- Primary DI
- 08800015913638
- Version / Model
- NA1016
- Company Name
- CG MedTech Co.,Ltd.
- Labeler DUNS
- 688811082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 10
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- 61fb9e3f-0473-444a-9b14-6548bf27b48c
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65265 | Arthrodesis intramedullary nail, magnetic distraction | A rigid magnetic rod, capable of adjusting in length (lengthen), dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone (e.g., tibia) which extends beyond the joint to an adjacent bone(s) [e.g., calcaneus], in traumatic repair or reconstructive procedures. It consists of telescoping rods connected to the bone with screws, which have one or more integrated magnets that are designed to move in response to a noninvasive magnetic control device (not included) to adjust length providing distraction. It is made of metal or other material (e.g., carbon fibre). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800015913638 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120419 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place.