FDA UDI
In Commercial Distribution
🇺🇸 United States
Epimed
DI: 00818788023629
·
Model: 119-2080
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed
- Primary DI
- 00818788023629
- Version / Model
- 119-2080
- Catalog Number
- 119-2080
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-17
- Public Version
- 1
- Public Version Date
- 2021-06-25
- Public Version Status
- New
- Public Device Record Key
- 1fdf1a6f-cf70-4716-b7df-a2a466bf8909
Device Description
20g TW x 8.0" Coudé® Blunt Nerve Block Needle w/ Introducer
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 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
- 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 |
|---|---|---|---|---|
| 59012 | Peripheral nerve-block blunt needle access cannula | A sterile flexible tube designed to provide percutaneous access to a peripheral nerve group for the insertion of a nerve-block blunt needle and injection of an anaesthetic/analgesic agent for nerve-block/pain control. It is typically made of plastic and contains a sharp-tipped metal needle to facilitate its introduction which may be guided by fluoroscopy. Once introduced, the sharp needle is intended to be removed so the cannula can be used as a conduit for the nerve-block blunt needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10818788023626 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00818788023629 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041843 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8.0in | ||
| Needle Gauge | 20 | Gauge | |
| Device Size Text, specify | 20g | ||
| Length | 8 | Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit