FDA UDI
In Commercial Distribution
🇺🇸 United States
EchoStim MSK
DI: 04526737171234
·
Model: EBA-22100
·
HAKKO CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- EchoStim MSK
- Primary DI
- 04526737171234
- Version / Model
- EBA-22100
- Company Name
- HAKKO CO.,LTD.
- Labeler DUNS
- 693273427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-01
- Public Version
- 1
- Public Version Date
- 2022-10-10
- Public Version Status
- New
- Public Device Record Key
- 47ef57cd-6a61-42e9-8fad-2d6f48f058d8
Device Description
22G x 4"(100mm) Facet tip, 18 degree bevel with screw on tubing non-insulated
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 46382 | Peripheral anaesthesia single-administration set, non-medicated | A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14526737171231 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 04526737171234 | GS1 | ||||
| Previous | 04526737170756 | GS1 |
Customer Contacts
- Phone
- 513-271-2117
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063380 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 22 | Gauge | |
| Length | 100 | Millimeter |