FDA UDI
In Commercial Distribution
🇺🇸 United States
Non-Sterile Probe Storage Covers
DI: 50841912104265
·
Model: 1160
·
PROTEK MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Non-Sterile Probe Storage Covers
- Primary DI
- 50841912104265
- Version / Model
- 1160
- Catalog Number
- 1160
- Company Name
- PROTEK MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 965417181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-06-10
- Public Version
- 1
- Public Version Date
- 2019-06-18
- Public Version Status
- New
- Public Device Record Key
- 2a34ac65-51d4-44dd-bd75-a0e30b09df33
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63712 | Medical equipment drape, single-use, non-sterile | A non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60841912104262 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 50841912104265 | GS1 | ||||
| Unit of Use | 00841912104260 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970889 | 000 |