FDA UDI
In Commercial Distribution
🇺🇸 United States
OPTICS ONE
DI: 00815384020366
·
Model: 4705-40
·
MEDICAL TECHNIQUE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OPTICS ONE
- Primary DI
- 00815384020366
- Version / Model
- 4705-40
- Catalog Number
- 4705-40
- Company Name
- MEDICAL TECHNIQUE, INC.
- Labeler DUNS
- 790514756
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 86b88670-d035-4468-80d6-65d89b72b777
Device Description
Zeiss Bonnet Cover 20 in Dia w/48mm Lens
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Package | 00815384020380 | GS1 | CASE | 2 | In Commercial Distribution | |
| Package | 00815384020373 | GS1 | INNER PACK | 20 | In Commercial Distribution | |
| Primary | 00815384020366 | GS1 |
Customer Contacts
- Phone
- 520-733-7999
- [email protected]