FDA UDI
In Commercial Distribution
🇺🇸 United States
MSK Ultrasonic Injection Needle
DI: M661S80C21200
·
Model: S80C21-2.00BLX
·
Spectra Medical Devices, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MSK Ultrasonic Injection Needle
- Primary DI
- M661S80C21200
- Version / Model
- S80C21-2.00BLX
- Company Name
- Spectra Medical Devices, LLC
- Labeler DUNS
- 118301171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-12
- Public Version
- 1
- Public Version Date
- 2024-02-20
- Public Version Status
- New
- Public Device Record Key
- 1e4207cc-6375-4ea6-8609-b222a51c4b07
Device Description
21G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lubricated, Molded Protector with Extension Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 | M661S80C21200 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151069 | 000 |