FDA UDI
In Commercial Distribution
🇺🇸 United States
STERILISATION TRAY
DI: 04049539100610
·
Model: 303060-0350-000
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STERILISATION TRAY
- Primary DI
- 04049539100610
- Version / Model
- 303060-0350-000
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-25
- Public Version
- 1
- Public Version Date
- 2022-05-03
- Public Version Status
- New
- Public Device Record Key
- 4a58a51a-9f09-43fb-887c-1bb13884a67f
Device Description
This re-usable device is an accessory for ZEISS phaco systems. It is used to store medical accessories during steam sterilization to ensure that reproducible sterilization results are obtained.
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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42997 | Surgical instrument/implant rack | A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539100610 | GS1 |