FDA UDI
In Commercial Distribution
🇺🇸 United States
UpLivt
DI: 10816286021175
·
Model: 5200
·
BOEHRINGER LABORATORIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- UpLivt
- Primary DI
- 10816286021175
- Version / Model
- 5200
- Company Name
- BOEHRINGER LABORATORIES, LLC
- Labeler DUNS
- 079991657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-16
- Public Version
- 1
- Public Version Date
- 2025-07-24
- Public Version Status
- New
- Public Device Record Key
- 44d6e44a-5264-4e73-9e70-e8605658b190
Device Description
UpLivt Liver Retractor
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | 70816286021177 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 10816286021175 | GS1 |
Customer Contacts
- Phone
- 610-278-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243399 | 000 |