FDA UDI
In Commercial Distribution
🇺🇸 United States
Epimed
DI: 00818788023636
·
Model: 116-2020
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed
- Primary DI
- 00818788023636
- Version / Model
- 116-2020
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-23
- Public Version
- 1
- Public Version Date
- 2024-05-31
- Public Version Status
- New
- Public Device Record Key
- 920fc7af-ebf5-41bc-b23c-6b5cb3404dd1
Device Description
20g TW x 2.0" Blunt Nerve Block Needle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 45178 | Peripheral nerve-block blunt needle | A sterile slender hand-held metal tube with a dull, straight or bent (coude) tip designed to atraumatically access a peripheral nerve for the injection of 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 |
|---|---|---|---|---|---|---|
| Package | 10818788023633 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00818788023636 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041843 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2.0 | Inch | |
| Needle Gauge | 20 | Gauge |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit