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Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit FDA UDI
- Generic Name
- Peripheral nerve-block sharp needle FDA UDI
- Device Name
- Mini-Kit, 100mm w/ filter FDA UDI
- Model / Reference
- 500020 FDA UDI
- Description
- Mini-Kit, 100mm w/ filter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001913102 FDA UDI
- 510(k) Number
- K151072 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Peripheral nerve-block sharp needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 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
Yes
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
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Category: Peripheral nerve-block sharp needle
Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit by Solo-Dex, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral nerve-block sharp needle.
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- SONO MSK — Pajunk GmbH Medizintechnologie · Class II
- Temena — Te ME NA Sas · Class II
- Temena — Te ME NA Sas · Class II
- Temena — Te ME NA Sas · Class II
- Spinal Needle — HAKKO CO., LTD. · Class II
Cleared under the same submission
K151072 also covers:
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Set — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Set — Solo-Dex, Inc
- Fascile Continuous Peripheral Nerve Block Set — Solo-Dex, Inc
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
- Solo-Dex, Inc
Sources (1)
- FDA UDI e7a16b86-dd6b-44e4-901e-65ba6d02d7c5 34 fields · synced Jun 8, 2026