FDA UDI
In Commercial Distribution
🇺🇸 United States
AMADEUS
DI: 07640167751211
·
Model: SurePass
·
SIS AG, Surgical Instrument Systems
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- AMADEUS
- Primary DI
- 07640167751211
- Version / Model
- SurePass
- Catalog Number
- 130.700.001
- Company Name
- SIS AG, Surgical Instrument Systems
- Labeler DUNS
- 480508261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 75034bdf-7519-4d32-ae6c-c47588099818
Device Description
SurePass sterile blade for AMADEUS
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
- 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
- No
- 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 |
|---|---|---|---|---|
| HNO | Keratome, Ac-Powered | Ophthalmic | 886.4370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44722 | Keratome blade, single-use | A surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640167751211 | GS1 | ||||
| Unit of Use | 07640167751228 | GS1 |
Customer Contacts
- Phone
- 8667084490
- [email protected]