Elite Medtek

GUDID 06939147402276

Elite Medtek (Jiangsu) Co., Ltd.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use
Primary Device ID06939147402276
NIH Device Record Key812d7962-849e-4a96-b416-b13f16334d0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite Medtek
Version Model NumberEM-ID-M14S
Company DUNS542974341
Company NameElite Medtek (Jiangsu) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS106939147402276 [Primary]
GS116939147402280 [Package]
Package: [5 Units]
In Commercial Distribution
GS126939147402294 [Package]
Contains: 16939147402280
Package: [20 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


[06939147402276]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-27
Device Publish Date2020-08-19

On-Brand Devices [Elite Medtek]

06939147402030EM-ID-M30S
06939147402276EM-ID-M14S

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