Jeato 7 Incontinence Clamp

GUDID 08800064400103

Jeato Med. CO., Ltd.

Incontinence penis clamp, reusable
Primary Device ID08800064400103
NIH Device Record Key66c0ef46-9b0d-4bd8-a8fd-63bcde9f0852
Commercial Distribution StatusIn Commercial Distribution
Brand NameJeato 7 Incontinence Clamp
Version Model NumberJC002
Company DUNS694810374
Company NameJeato Med. CO., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800064400103 [Primary]

FDA Product Code

FHAClamp, Penile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

Devices Manufactured by Jeato Med. CO., Ltd.

08800064400004 - Jeato Incontinence Clamp2022-11-22
08800064400028 - Jeato Replacement Pads 8T (Upper)2022-11-22
08800064400035 - Jeato Replacement Pads 10T (Upper)2022-11-22
08800064400042 - Jeato Replacement Pads 11T (Upper)2022-11-22
08800064400066 - Jeato Replacement Pads 8T (Lower)2022-11-22
08800064400073 - Jeato Replacement Pads 10T (Lower)2022-11-22
08800064400080 - Jeato Replacement Pads 11T (Lower)2022-11-22
08800064400097 - Jeato Replacement Pads All Siz2022-11-22

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