Identity
- Trade Name
- Access Needle FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- Access Needle, Intergrated Bevel Tip, 115mm, 11G FDA UDI
- Model / Reference
- FG3018 FDA UDI
- Description
- Access Needle, Intergrated Bevel Tip, 115mm, 11G FDA UDI
Identifiers
- Catalog Number
- FG3018 FDA UDI
- Primary DI / UDI-DI
- 06938695537751 FDA UDI
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- NDN FDA UDIHRX FDA UDI
- GMDN Term
- Bone access channel kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.1100 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 — 3 Millimeter FDA UDILength — 115 Millimeter FDA UDI
Category: Bone access channel kit
Access Needle by Shanghai Kinetic Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone access channel kit.
- Keyfix bone drill 9G — G21 SRL · Class I
- Bevel — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Osseoflex® — Merit Medical Systems, Inc. · Class I
- OsteoCool™ Bone Access Kit — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- KYPHON® One-Step™ Osteo Introducer™ System — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- 0.035" x 5" K-Wire Standard — Trilliant Surgical LLC · Class II
- OSTEOCOOL KIT BONE ACCESS 10G 095 — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Kyphon V™ Osteo Introducer® 11Ga Bevel KIT — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Cleared under the same submission
K113742 also covers:
- 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.
- KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel 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 1891850e-963d-4030-97ea-9cae51ce1b95 38 fields · synced May 31, 2026