FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Protective Cap
DI: 10704411008422
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8000
Basic Information
- Brand Name
- AMSure® Protective Cap
- Primary DI
- 10704411008422
- Version / Model
- 1
- Catalog Number
- CAP1030
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8000
- Record Status
- Published
- Publish Date
- 2018-06-05
- Public Version
- 1
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 7739b759-11e6-4213-b932-1980b9ecd0f9
Device Description
AMSure® Protective Cap for 10 cc & 30 cc Syringes Radiation Resistant
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45548 | Radiation shielding head wear | A personal protective device intended to shield the head of an individual (i.e., the operator or other attending person) from unnecessary primary and scattered radiation during diagnostic or therapeutic medical procedures. It can be shaped like a cap or hood and will typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Head wear used for neutron attenuation is composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10704411008422 | GS1 | ||||
| Unit of Use | 40704411008423 | GS1 |