FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoLift
DI: M660EL000A52
·
Model: EL000A
·
VIRTUAL PORTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- EndoLift
- Primary DI
- M660EL000A52
- Version / Model
- EL000A
- Catalog Number
- EL000A5
- Company Name
- VIRTUAL PORTS LTD
- Labeler DUNS
- 514870547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-06-23
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- e853ba74-315e-494b-82fc-1e333686a4f7
Device Description
The EndoLift is intended to retract and shift internal organs during minimally invasive surgery. The EndoLift is an internally anchored, hands-free retracting device, which eliminates the need for a hand held retractor during surgery.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58096 | Internally-anchored endoscopic retractor | A sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M660EL000A52 | HIBCC | ||||
| Unit of Use | M660EL000A0 | HIBCC |