FDA UDI
Not in Commercial Distribution
🇺🇸 United States
None
DI: 00886874116111
·
Model: 490101
·
INTUITIVE SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- None
- Primary DI
- 00886874116111
- Version / Model
- 490101
- Company Name
- INTUITIVE SURGICAL, INC.
- Labeler DUNS
- 938647021
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-30
- Public Version
- 4
- Public Version Date
- 2020-08-26
- Public Version Status
- Update
- Public Device Record Key
- 2d8b02ce-ab64-4bb7-8f82-300933b0158f
- Distribution End Date
- 2020-08-26
Device Description
Vision Probe Adapter and Suction Adapter
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 |
|---|---|---|---|---|
| EOQ | Bronchoscope (flexible or rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37412 | Medical device cleaning jet handpiece | A hand-operated device designed to regulate and direct a narrow stream (a jet) of water and/or air for the initial cleaning of laboratory glassware, pipettes, syringes, certain endoscopes, cannulae, surgical instruments and other devices prior to disinfection/sterilization. It is usually in the form of a pistol with an activation trigger, and may be fitted with different nozzles or a variable nozzle. It is typically connected via tubing to a tap (faucet) and/or a pressurized air source. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10886874116118 | GS1 | BOX | 10 | Not in Commercial Distribution | 2020-08-26 |
| Primary | 00886874116111 | GS1 | ||||
| Package | 30886874116112 | GS1 | CASE | 90 | Not in Commercial Distribution | 2020-08-26 |