FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroTrace
DI: B33955522070
·
Model: 555-22-07
·
NEO MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroTrace
- Primary DI
- B33955522070
- Version / Model
- 555-22-07
- Catalog Number
- 555-22-07
- Company Name
- NEO MEDICAL INC.
- Labeler DUNS
- 015510540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a0bff738-2be6-4423-b1dc-31bf8f16ac93
Device Description
Insulated Electro-needle for use in Regional Anesthesia 22ga x 3.0" (76mm) Pencil Point / Whitacre Bevel
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
- Yes
- MRI Safety
- MR Unsafe
- 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
- 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 |
|---|---|---|---|---|
| 61546 | Nerve-locating anaesthesia needle | A sterile device intended to functions as: 1) an electrode during nerve/nerve plexus location; and 2) as a conduit for administration of a local anaesthetic during peripheral nerve-blocking. It is a sharp, hollow, tubular, electrically-insulated metal needle with an uninsulated bevelled tip, intended to be used with an electrical pulse generator and an appropriate anaesthetic-filled syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B33955522070 | HIBCC | ||||
| Package | B33955522075 | HIBCC | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-450-3334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032981 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 76 | Millimeter | |
| Length | 3.0 | Inch | |
| Needle Gauge | 22 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight