Everest / Megabio Rainbow

GUDID 08800118611455

U&C International Co.,Ltd

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Primary Device ID	08800118611455
NIH Device Record Key	79715f12-f1b4-41e0-af40-c4d689bf40b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Everest / Megabio Rainbow
Version Model Number	W ML PT B1 22
Company DUNS	694821663
Company Name	U&C International Co.,Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800118611455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191902

FDA Product Code

EIH	Powder, Porcelain

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-24
Device Publish Date	2022-02-16

On-Brand Devices [Everest / Megabio Rainbow]

08800118606857	Z ML AT A4 30
08800118606840	Z ML AT A4 28
08800118606833	Z ML AT A4 25
08800118606826	Z ML AT A4 22
08800118606819	Z ML AT A4 20
08800118606802	Z ML AT A4 18
08800118606796	Z ML AT A4 16
08800118606789	Z ML AT A4 14
08800118606772	Z ML AT A4 12
08800118606765	Z ML AT A4 10
08800118606758	Z ML AT A3.5 30
08800118606741	Z ML AT A3.5 28
08800118606734	Z ML AT A3.5 25
08800118606727	Z ML AT A3.5 22
08800118606710	Z ML AT A3.5 20
08800118606703	Z ML AT A3.5 18
08800118606697	Z ML AT A3.5 16
08800118606680	Z ML AT A3.5 14
08800118606673	Z ML AT A3.5 12
08800118606666	Z ML AT A3.5 10
08800118606659	Z ML AT A3 30
08800118606642	Z ML AT A3 28
08800118606635	Z ML AT A3 25
08800118606628	Z ML AT A3 22
08800118606611	Z ML AT A3 20
08800118606604	Z ML AT A3 18
08800118606598	Z ML AT A3 16
08800118606581	Z ML AT A3 14
08800118606574	Z ML AT A3 12
08800118606567	Z ML AT A3 10
08800118606550	Z ML AT A2 30
08800118606543	Z ML AT A2 28
08800118606536	Z ML AT A2 25
08800118606529	Z ML AT A2 22
08800118606512	Z ML AT A2 20
08800118606505	Z ML AT A2 18
08800118606499	Z ML AT A2 16
08800118606482	Z ML AT A2 14
08800118606475	Z ML AT A2 12
08800118606468	Z ML AT A2 10
08800118606451	Z ML AT A1 30
08800118606444	Z ML AT A1 28
08800118606437	Z ML AT A1 25
08800118606420	Z ML AT A1 22
08800118606413	Z ML AT A1 20
08800118606406	Z ML AT A1 18
08800118606390	Z ML AT A1 16
08800118606383	Z ML AT A1 14
08800118606376	Z ML AT A1 12
08800118606369	Z ML AT A1 10