Identity
- Trade Name
- Dilator w/Cannula FDA UDI
- Generic Name
- Periodontal disease-associated bacteria/genetic risk factor IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Dilator w/Cannula, 8G (4.2mm) FDA UDI
- Model / Reference
- FG2410 FDA UDI
- Description
- Dilator w/Cannula, 8G (4.2mm) FDA UDI
Identifiers
- Catalog Number
- FG2410 FDA UDI
- Primary DI / UDI-DI
- 06938695537676 FDA UDI
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- HRX FDA UDINDN FDA UDI
- GMDN Term
- Periodontal disease-associated bacteria/genetic risk factor IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.2 Millimeter FDA UDI
Category: Periodontal disease-associated bacteria/genetic risk factor IVD, kit, nucleic acid technique (NAT)
Dilator w/Cannula by Shanghai Kinetic Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K113742 also covers:
- Access Needle — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter Curved — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter Syringe Pump — Shanghai Kinetic Medical Co., Ltd.
- Bone Filler Device — Shanghai Kinetic Medical Co., Ltd.
- Bone Filler Device — Shanghai Kinetic Medical Co., Ltd.
- Cannula — Shanghai Kinetic Medical Co., Ltd.
- Drill — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip — Shanghai Kinetic Medical Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
Sources (1)
- FDA UDI 684eeef0-52d9-4300-b1b0-f9d29c057ae7 38 fields · synced May 30, 2026