FDA UDI
In Commercial Distribution
🇺🇸 United States
OPMI® Drapes sterile
DI: 04049539101266
·
Model: 326009-0000-000
·
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 sterile
- Primary DI
- 04049539101266
- Version / Model
- 326009-0000-000
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6921a88e-d5af-44c2-99e2-53dc23d7f8e6
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 45021 | Instrument/equipment drape, single-use, sterile | A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539101266 | GS1 | ||||
| Package | 04049539102058 | GS1 | 15 | In Commercial Distribution | ||
| Package | 04049539102263 | GS1 | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 59 | Inch | |
| Width | 20 | Inch | |
| Height | 150 | Centimeter | |
| Width | 51 | Centimeter |