FDA UDI
In Commercial Distribution
🇺🇸 United States
Dilator w/Cannula
DI: 06938695537676
·
Model: FG2410
·
Shanghai Kinetic Medical Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dilator w/Cannula
- Primary DI
- 06938695537676
- Version / Model
- FG2410
- Catalog Number
- FG2410
- Company Name
- Shanghai Kinetic Medical Co., Ltd.
- Labeler DUNS
- 528198569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-31
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 684eeef0-52d9-4300-b1b0-f9d29c057ae7
Device Description
Dilator w/Cannula, 8G (4.2mm)
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60748 | Periodontal disease-associated bacteria/genetic risk factor IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple bacteria associated with periodontal disease, and for determining the genetic risk for developing periodontal disease based on detection of gene fragments coding for interleukin-1-alpha and interleukin-1-beta, and the DRB1*04 gene coding for HLA-DR4 in a clinical specimen, using a multiplex method. Organisms detected may include (but are not limited to) Porphyromonas, Prevotella, Tannerella, Actinobacillus and/or Treponema species. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06938695537676 | GS1 |
Customer Contacts
- Phone
- +862150720558
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113742 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.2 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius