FDA UDI
In Commercial Distribution
🇺🇸 United States
OPMI® Drapes
DI: 04049539101174
·
Model: 326044-0000-000
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- OPMI® Drapes
- Primary DI
- 04049539101174
- Version / Model
- 326044-0000-000
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 5
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- bc82368a-31cb-48f6-838a-d86f04418541
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
- 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
- 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 |
|---|---|---|---|---|
| 58976 | Medical equipment/instrument drape, reusable | A noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity, of a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04049539102171 | GS1 | 10 | In Commercial Distribution | ||
| Package | 04049539101969 | GS1 | 15 | In Commercial Distribution | ||
| Primary | 04049539101174 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 43 | Inch | |
| Width | 19 | Inch | |
| Height | 110 | Centimeter | |
| Width | 49 | Centimeter |