Standard Trocar

GUDID 10851677007048

STANDARD BARIATRICS, INC

Laparoscopic access cannula, single-use
Primary Device ID10851677007048
NIH Device Record Keye225376e-2d0a-47b6-b263-861c4e5aa802
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Trocar
Version Model NumberST19-1
Company DUNS091278068
Company NameSTANDARD BARIATRICS, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851677007041 [Primary]
GS110851677007048 [Package]
Contains: 00851677007041
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

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Trademark Results [Standard Trocar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STANDARD TROCAR
STANDARD TROCAR
88878000 not registered Live/Pending
Standard Bariatrics, Inc.
2020-04-19

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