FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Stimuplex®
DI: 04046955094608
·
Model: 4894251NR-02
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Stimuplex®
- Primary DI
- 04046955094608
- Version / Model
- 4894251NR-02
- Catalog Number
- 4894251NR-02
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-02-02
- Public Version
- 2
- Public Version Date
- 2023-03-31
- Public Version Status
- Update
- Public Device Record Key
- e368c7bf-a85b-473d-9e6b-aec49462a82b
- Distribution End Date
- 2023-03-29
Device Description
STIMUPLEX A, 30°, 24GX25MM NRFIT-US
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| BXN | STIMULATOR, NERVE, BATTERY-POWERED | Anesthesiology | 868.2775 | 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 |
|---|---|---|---|---|---|---|
| Primary | 04046955094608 | GS1 | ||||
| Unit of Use | 04046955090747 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]