Identity
- Trade Name
- TRACKER FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- Needle Pin FDA UDI
- Model / Reference
- GCD-NP1-E FDA UDI
- Description
- Needle Pin FDA UDI
Identifiers
- Catalog Number
- GCD-NP1-E FDA UDI
- Primary DI / UDI-DI
- 08806162110999 FDA UDI
- 510(k) Number
- K192335 FDA UDI
- FDA Product Code
- HRX FDA UDINDN FDA UDI
- GMDN Term
- Balloon kyphoplasty kit 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Balloon kyphoplasty kit
Tracker by GS Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Balloon kyphoplasty kit.
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- KMC Double Balloon Assembly, 8 Gauge, 20mm — Shanghai Kinetic Medical Co., Ltd. · Class II
- Zavation — ZAVATION · Class II
- SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
- Zavation — ZAVATION · Class II
Cleared under the same submission
K192335 also covers:
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS Medical Co., Ltd.
- TRACKER — GS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GS Medical Co., Ltd.
Sources (1)
- FDA UDI 3b377c73-27e9-46c4-b7c3-f717015f1055 36 fields · synced May 30, 2026