Identity
- Trade Name
- Stop'n GO Double Balloon Catheter FDA UDI
- Generic Name
- Kyphoplasty balloon catheter FDA UDI
- Model / Reference
- US9420 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250203940870 FDA UDI
- 510(k) Number
- K192449 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Kyphoplasty balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Category: Kyphoplasty balloon catheter
Stop'n GO Double Balloon Catheter by Joline GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192449 also covers:
- Access Kit — Joline GmbH & Co. KG
- Allevo Curette — Joline GmbH & Co. KG
- Balloon Adapter — Joline GmbH & Co. KG
- Best Kit 16/16 — Joline GmbH & Co. KG
- Best Kit 16/16 — Joline GmbH & Co. KG
- Best Kit 22/16 — Joline GmbH & Co. KG
- Best Kit 22/16 — Joline GmbH & Co. KG
- Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm — Joline GmbH & Co. KG
- Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm — Joline GmbH & Co. KG
- Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm — Joline GmbH & Co. KG
- Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm — Joline GmbH & Co. KG
- Best Kit SpeedTrack Stop'n GO 2 x 8 mm — Joline GmbH & Co. KG
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
- Joline GmbH & Co. KG
Sources (1)
- FDA UDI 93b5ab6b-6e58-417c-b08d-e3fe9da6d944 33 fields · synced May 31, 2026