FDA.reportPublic FDA data

MEDIVISION

Primary DI
00851328007161
Brand
MEDIVISION
Company
MEDIVISION, INC.
Model
MV1045
Catalog number
MV1045
Device description
The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851328007161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851328007161008513280071618513280071610851328007161

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
942192550
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851328007000MEDIVISIIONMVA2702MVA27022016-12-14
00851328007017MEDIVISIONMVA2701MVA27012016-12-14
00851328007024MEDIVISIONMVA2731MVA27312016-12-14
00851328007031MEDIVISIONMVA2732MVA27322016-12-14
00851328007048MEDIVISIONMVA400SMVA400S2016-12-14
00851328007055MEDIVISIONMVA430SMVA430S2016-12-14
00851328007062MEDIVISIONMVA470SMVA470S2016-12-14
00851328007079MediVisionMVA400MVA4002016-12-14
00851328007086MediVisionMVA430MVA4302016-12-07
00851328007093MediVisionMVA445MVA4452016-12-14
00851328007109MEDIVISIONMVA470MVA4702016-12-14
00851328007178MEDIVISIONMV2900MV29002016-12-14
00851328007185MEDIVISIONMV2930MV29302016-12-14
00851328007192MEDIVISIONMV400MV4002016-12-14
00851328007208MEDIVISIONMV412MV4122016-12-14
00851328007215MEDIVISIONMV430MV4302016-12-14
00851328007222MEDIVISIONMV470MV4702016-12-14
00851328007239PureDefense Surgical MaskVQN0185WVQN0185W2020-05-12
00851328007246PureDefense Surgical MaskVQN0185BVQN0185B2020-05-12
00851328007116MEDIVISIONMV5500MV55002016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24