Ligation Device Loop20B0-LD195D0

GUDID 06923646508683

Leo Medical Co., Ltd.

Polypectomy endoscopic ligator, single-use
Primary Device ID06923646508683
NIH Device Record Key69a35571-ab97-431e-9a49-935cff633943
Commercial Distribution StatusIn Commercial Distribution
Brand NameLigation Device
Version Model NumberLoop20B0-LD195D0
Catalog NumberLoop20B0-LD195D0
Company DUNS421371962
Company NameLeo 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106923646508683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FHNLigator, Hemorrhoidal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-12
Device Publish Date2026-01-04

On-Brand Devices [Ligation Device]

06923646508737Loop30B0-LD230D0
06923646508638Loop15B0-LD165D0
06923646508744Loop40B0-LD230D0
06923646508720Loop20B0-LD230D0
06923646508713Loop15B0-LD230D0
06923646508706Loop40B0-LD195D0
06923646508690Loop30B0-LD195D0
06923646508683Loop20B0-LD195D0
06923646508676Loop15B0-LD195D0
06923646508669Loop40B0-LD165D0
06923646508652Loop30B0-LD165D0
06923646508645Loop20B0-LD165D0

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