FDA UDI
In Commercial Distribution
🇺🇸 United States
Anovo Pedestal
DI: 07290018151297
·
Model: 1.00.000
·
MOMENTIS SURGICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Anovo Pedestal
- Primary DI
- 07290018151297
- Version / Model
- 1.00.000
- Catalog Number
- FP-05-0002
- Company Name
- MOMENTIS SURGICAL LTD
- Labeler DUNS
- 600482439
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-25
- Public Version
- 1
- Public Version Date
- 2025-04-02
- Public Version Status
- New
- Public Device Record Key
- e714ffcb-039c-4b57-9a66-20b7c078c7fb
Device Description
The Pedestal is an accessory to the Anovo Surgical System which supports the RCU during the surgical procedure. The Pedestal is a non-sterile, reusable component, operated by a hospital power grid. The Pedestal's wheels enable easy and convenient positioning of the Anovo RCU in the desired position in front of the point of entry.
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| QNM | Mountable Electromechanical Surgical System For Transluminal Approaches | General, Plastic Surgery | 878.4961 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62380 | Surgical instrument assist arm system, power-adjusted | A device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290018151355 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 07290018151297 | GS1 |