15072025GUDIDSync1

GUDID 03400420000029

NEWCLIP TECHNICS

Vimentin IVD, calibrator
Primary Device ID03400420000029
NIH Device Record Keycfafecf3-fbf9-49df-920b-68558ff1434e
Commercial Distribution StatusIn Commercial Distribution
Brand Name15072025GUDIDSync1
Version Model Number15072025GUDIDSync1
Company DUNS263281904
Company NameNEWCLIP TECHNICS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103400420000029 [Primary]

FDA Product Code

FRTUNIT, ISOLATION, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


[03400420000029]

Chlorine Dioxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-20
Device Publish Date2025-08-12

Devices Manufactured by NEWCLIP TECHNICS

03400420000050 - 06082025GUDIDSync2.0012025-08-22
03400420000029 - 15072025GUDIDSync12025-08-20
03400420000029 - 15072025GUDIDSync12025-08-20
03700569604233 - Alians Clavicle2024-11-25
03700569604257 - Alians Clavicle2024-11-25
03700569604271 - Alians Clavicle2024-11-25
03700569604295 - Alians Clavicle2024-11-25
03700569604318 - Alians Clavicle2024-11-25
03700569604332 - Alians Clavicle2024-11-25

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