FDA UDI
In Commercial Distribution
🇺🇸 United States
Sapphire PCA Lockbox 500mL Label
DI: 07290109155296
·
Model: 15062-131-0010
·
EITAN MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sapphire PCA Lockbox 500mL Label
- Primary DI
- 07290109155296
- Version / Model
- 15062-131-0010
- Company Name
- EITAN MEDICAL LTD
- Labeler DUNS
- 533108028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-29
- Public Version
- 1
- Public Version Date
- 2024-12-09
- Public Version Status
- New
- Public Device Record Key
- 9ac67021-cac1-4f84-9a9b-64d1abe39f22
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34886 | Narcotics security storage cabinet | A furniture-like device specially designed to provide a secure storage for narcotics. It can have double walls, two locks with separate keys, reinforced hinges, and other security design measures to prevent illegal entrance. Such cabinets will typically be installed in hospital wards or institutions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109155296 | GS1 |