Endoplus

Primary DI
00817401024166
Brand
Endoplus
Company
Endoplus
Model
E341MR-45
Device description
5mm Curved Maryland Dissector, Monopolar Handle, With Rotation, 45cm
Published
2016-10-31
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
HFICoagulator, Culdoscopic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFICoagulator, Culdoscopic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925114000LAPAROSCOPIC INSTRUMENTSEndo Technic Corp.1994-02-28HFI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817401024166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817401024166008174010241668174010241660817401024166

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
794679167
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817401029147EndoplusE332RR-452026-05-13
00817401029154EndoplusE382RR-452026-05-13
00817401029130EndoplusE322S2026-02-06
00817401029123EndoplusE404RR2026-01-16
00817401029116EndoplusE404RR-452025-12-19
00817401029109EndoplusE356SL2025-04-10
00817401029093EndoplusE308RR-452025-03-14
00817401029079EndoplusE339SLR2024-12-13
00817401029086EndoplusE302R2024-12-13
00817401029062EndoplusE363RR-452024-11-21
00817401029048EndoplusE382MR2024-08-30
00817401029055EndoplusE382RR2024-08-30
00817401028614EndoplusE300DVR2024-04-30
00817401028621EndoplusE300DVR-452024-04-30
00817401028638EndoplusE307DVR2024-04-30
00817401028645EndoplusE307DVR-452024-04-30
00817401028652EndoplusE313DVR2024-04-30
00817401028669EndoplusE313DVR-452024-04-30
00817401028676EndoplusE317DVR2024-04-30
00817401028683EndoplusE317DVR-452024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029048EndoplusEndoplusHFI2024-08-30
00817401028416EndoplusEndoplusHFI2022-07-08
00817401028423EndoplusEndoplusHFI2022-07-08
00817401028393EndoplusEndoplusHFI2022-03-10
00817401028140EndoplusEndoplusHFI2021-07-23
00817401027969EndoplusEndoplusHFI2021-05-26
00817401027976EndoplusEndoplusHFI2021-05-26
14042761086254OlympusOLYMPUS Winter & Ibe GmbHHFI2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFI2020-07-31
00817401027754EndoplusEndoplusHFI2020-06-26
00817401027495EndoplusEndoplusHFI2019-06-26
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