FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 30382904051939
·
Model: 405193
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- N/A
- Primary DI
- 30382904051939
- Version / Model
- 405193
- Catalog Number
- 405193
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2025-08-07
- Public Version Status
- Update
- Public Device Record Key
- b48570af-100e-41aa-a70e-d5ef9fb66cb1
Device Description
NEEDLE EPIDURAL S/SU 17GA TW 5IN WEISS
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 |
|---|---|---|---|---|
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58293 | Epidural needle, non-threaded | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382904051939 | GS1 | ||||
| Unit of Use | 00382904051938 | GS1 | ||||
| Package | 50382904051933 | GS1 | Case | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211085 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Inch | |
| Needle Gauge | 17 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry