FDA UDI
In Commercial Distribution
🇺🇸 United States
Microscope Cover MITAKA 120/390 HLT
DI: 07290010812684
·
Model: 80-570HRM
·
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Microscope Cover MITAKA 120/390 HLT
- Primary DI
- 07290010812684
- Version / Model
- 80-570HRM
- Company Name
- PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
- Labeler DUNS
- 532186541
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-13
- Public Version
- 1
- Public Version Date
- 2022-11-21
- Public Version Status
- New
- Public Device Record Key
- bd41c7bf-337a-474e-a01e-e925f8b047f9
Device Description
Operating room microscope cover
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A 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 neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290010812681 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 07290010812684 | GS1 | ||||
| Package | 27290010812688 | GS1 | box | 3 | In Commercial Distribution |