FMsealer FM4001

GUDID 20859729006169

FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length

DOMAIN SURGICAL, INC.

Electrosurgical handpiece, single-use
Primary Device ID20859729006169
NIH Device Record Key145a4b8e-5172-4287-aeda-640c5d4f465d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMsealer
Version Model Number4001
Catalog NumberFM4001
Company DUNS963249342
Company NameDOMAIN SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859729006165 [Primary]
GS110859729006162 [Package]
Contains: 00859729006165
Package: Sterile Pouch [1 Units]
In Commercial Distribution
GS120859729006169 [Package]
Contains: 10859729006162
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [FMsealer]

20859729006169FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length
20859729006152FMsealer Open Shears

Trademark Results [FMsealer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FMSEALER
FMSEALER
86323350 5046048 Live/Registered
Domain Surgical, Inc.
2014-06-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.