FDA UDI
In Commercial Distribution
🇺🇸 United States
Dyna Locking Trochanteric Nail
DI: 08800015948999
·
Model: NG9001
·
Innosys Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dyna Locking Trochanteric Nail
- Primary DI
- 08800015948999
- Version / Model
- NG9001
- Company Name
- Innosys Co., Ltd.
- Labeler DUNS
- 688811082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-31
- Public Version
- 4
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- e405817b-12b8-4a94-93ac-d1a32f0e43b9
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
- Yes
- 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 |
|---|---|---|---|---|
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64024 | Tissue pick | A hand-held manual surgical instrument designed primarily to hook/grasp skin to lift the skin and adjacent tissues during a surgical intervention. It is a shaft-like metallic instrument with a proximal handle and two small opposing (i.e., curved in opposite directions) sharp hooks at the distal end. When the device is placed onto the skin or tissue to be grasped, it is twisted clockwise so that the hooks lock into the skin/tissue. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800015948999 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place.