FDA.reportPublic FDA data

UpLivt

Primary DI
70816286021177
Brand
UpLivt
Company
BOEHRINGER LABORATORIES, LLC
Model
5200
Device description
UpLivt Liver Retractor
Published
2025-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243399000Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC2025-07-02GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70816286021177PackageGS110In Commercial Distribution
10816286021175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7081628602117770816286021177
1081628602117510816286021175

GMDN Terms#

Term, Definition table
TermDefinition
Internally-anchored endoscopic retractorA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-278-0900info@boehringerlabs.com

Regulatory Flags#

DUNS number
079991657
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816286021182Boehringer Surgical Suction Device50302025-11-24
20816286021189Boehringer Surgical Suction Device50302025-11-24
10816286021175UpLivt 52002025-07-16
10816286021120BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
10816286021137BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
30816286021124BOEHRINGER® ViSiGi Lux 36 Fr5336SB2025-05-20
30816286021131BOEHRINGER® ViSiGi Lux 40 Fr5340SB2025-05-20
10816286021151BOEHRINGER® CareDry™ Male System76802024-12-31
20816286021158BOEHRINGER® CareDry™ Male System76802024-12-31
10816286021168BOEHRINGER® Offset Mount - Four Inches90612024-12-31
10816286021076BOEHRINGER® CareDry™ System76602021-11-01
10816286020659BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System52502016-08-01
10816286021083TruLim Length Indicating Device501050102022-06-21
10816286020932BOEHRINGER® Smoke Removal System57002020-02-01
10816286020079BOEHRINGER® Care 4™ Suction Regulator, Intermittent/Continuous, 0-200, off/ cont384438442016-08-01
10816286021144BOEHRINGER® CareDry™ System76652023-12-29
20816286021141BOEHRINGER® CareDry™ System76652023-12-29
10816286020949BOEHRINGER® CareDry™ Regulator PST763076302020-01-15
10816286021014BOEHRINGER® Disposable Regulator 100-150mmHg765076502020-04-07
10816286021038BOEHRINGER® CareDry™ Wand764076402021-01-01

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