FDA UDI
In Commercial Distribution
🇺🇸 United States
POWER SUPPLY: ASSEMBLY FOR ROSI
DI: 00817122020423
·
Model: 200796
·
VASCULAR TECHNOLOGY, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POWER SUPPLY: ASSEMBLY FOR ROSI
- Primary DI
- 00817122020423
- Version / Model
- 200796
- Catalog Number
- 200796
- Company Name
- VASCULAR TECHNOLOGY, INCORPORATED
- Labeler DUNS
- 161989343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2024-02-08
- Public Version Status
- Update
- Public Device Record Key
- 28616a5c-245d-454a-8a66-70fcedc922d1
Device Description
Part Number 200796, POWER SUPPLY: ASSEMBLY FOR ROSI
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33579 | Surgical irrigation/aspiration pump, reusable | An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817122020423 | GS1 |
Customer Contacts
- Phone
- +1(603)594-9700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141323 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 12 – 40 Degrees Celsius