FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Epimed
DI: 00818788021465
·
Model: 189-2260
·
EPIMED INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epimed
- Primary DI
- 00818788021465
- Version / Model
- 189-2260
- Catalog Number
- 189-2260
- Company Name
- EPIMED INTERNATIONAL, INC
- Labeler DUNS
- 799751953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-24
- Public Version
- 5
- Public Version Date
- 2023-08-21
- Public Version Status
- Update
- Public Device Record Key
- baeee3bd-d228-4f29-a4a1-e088cf8bea64
- Distribution End Date
- 2023-08-18
Device Description
Wiley Spinal® 6"
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
- Yes
- 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 |
|---|---|---|---|---|
| 46308 | Epidural/intrathecal anaesthesia set, non-medicated | A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-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 | 10818788021462 | GS1 | Case | 10 | Not in Commercial Distribution | 2023-08-18 |
| Primary | 00818788021465 | GS1 |
Customer Contacts
- Phone
- +1(800)866-3342
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043467 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22g | ||
| Length | 6 | Inch | |
| Device Size Text, specify | 6.0" |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit