FDA UDI
In Commercial Distribution
🇺🇸 United States
Robotic FloShield/Plus
DI: 00815128020614
·
Model: RTS1
·
MINIMALLY INVASIVE DEVICES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Robotic FloShield/Plus
- Primary DI
- 00815128020614
- Version / Model
- RTS1
- Catalog Number
- RTS1
- Company Name
- MINIMALLY INVASIVE DEVICES, INC.
- Labeler DUNS
- 793517660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-29
- Public Version
- 3
- Public Version Date
- 2019-04-09
- Public Version Status
- Update
- Public Device Record Key
- 5e034c87-f809-4107-87d0-4727b96fac86
Device Description
FloShield/Plus Robotic Tube Set is an accessory for 8.5mm FloShield Robotic Sheath Assembly but is also compatible with 5mm FloShield and 10mm FloShield systems
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
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61204 | Endoscope lens cleaner, gas/fluid, single-use | A sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815128020614 | GS1 |
Customer Contacts
- Phone
- 1-614-340-3349
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 115 Degrees Fahrenheit