FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroTrace
DI: B33955718090
·
Model: 557-18-09
·
Neo Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NeuroTrace
- Primary DI
- B33955718090
- Version / Model
- 557-18-09
- Catalog Number
- 557-18-09
- 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
- 5
- Public Version Date
- 2025-07-22
- Public Version Status
- Update
- Public Device Record Key
- e9fc37bd-da3d-4826-bb40-f70292e5c6db
Device Description
Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 3.5" (89 mm), Tuohy 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 |
|---|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46383 | Peripheral anaesthesia catheter set, non-medicated | A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B33955718090 | HIBCC | ||||
| Package | B33955718095 | HIBCC | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-450-3334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K994059 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 89 | Millimeter | |
| Length | 3.5 | Inch | |
| Needle Gauge | 18 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry