Laport N21-0510

GUDID 88806182210378

Sejong Medical Co., Ltd

Laparoscopic access cannula, single-use
Primary Device ID88806182210378
NIH Device Record Keyb204f879-1875-427d-b62f-7f59254a5dae
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaport
Version Model NumberN21-0510
Catalog NumberN21-0510
Company DUNS689850476
Company NameSejong Medical Co., Ltd
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806182210372 [Primary]
GS118806182210379 [Package]
Contains: 08806182210372
Package: INBOX [10 Units]
In Commercial Distribution
GS188806182210378 [Package]
Contains: 18806182210379
Package: CARTON [8 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2018-04-05

On-Brand Devices [Laport]

88806182210873N20-0510
88806182210583N23-1210
88806182210514N23-0575
08806182210433N21-1110
88806182210392N21-0575
88806182210378N21-0510
88806182210330N22-0510

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