FDA UDI
In Commercial Distribution
🇺🇸 United States
Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
DI: 08500019130009
·
Model: 500014
·
Solo-Dex, Inc
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
- Primary DI
- 08500019130009
- Version / Model
- 500014
- Company Name
- Solo-Dex, Inc
- Labeler DUNS
- 118663297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 3
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- 5b04139a-6b51-40a9-b15c-c52fdd65c9d7
Device Description
Needle 20 gauge, Catheter 4 French X 70 mm Mini Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61547 | Peripheral nerve-block sharp needle | A sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08500019130009 | GS1 | ||||
| Package | 18500019130006 | GS1 | Box of 10 | 10 | In Commercial Distribution | |
| Package | 28500019130003 | GS1 | Box of 100 | 100 | In Commercial Distribution | |
| Previous | B372500001011 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151072 | 000 |