FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Safe-clip by Mail
DI: 00382903283354
·
Model: 328335
·
Becton, Dickinson and Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BD Safe-clip by Mail
- Primary DI
- 00382903283354
- Version / Model
- 328335
- Catalog Number
- 328335
- Company Name
- Becton, Dickinson and Company Inc
- Labeler DUNS
- 047047543
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6a802edf-497f-4f56-8e7d-627c68f19b41
Device Description
SAFE-CLIP BY MAIL
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38737 | Needle cutter | A device designed to cut a syringe needle to prevent its reuse. It typically includes a sharp metal cutting blade housed in a plastic container that receives the pieces of the destroyed needle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382903283359 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00382903283354 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K943683 | 000 |