INDALJIMTM

GUDID 07506561200246

Indaljim, S.A. de C.V.

Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall Surgical coverall
Primary Device ID07506561200246
NIH Device Record Key4f663c55-a968-4ea9-a919-6e5c76adee6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameINDALJIMTM
Version Model NumberOV-M
Company DUNS812753058
Company NameIndaljim, S.A. de C.V.
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 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
GS107506561200246 [Primary]

FDA Product Code

FXOSuit, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-07
Device Publish Date2022-01-28

On-Brand Devices [INDALJIMTM]

07506561200277BE-01
07506561200260OV-XL
07506561200253OV-L
07506561200246OV-M
07506561200239BMD-XL
07506561200222BMD-L
07506561200215BMD-M
07506561200130C3C-01
07506561200062GR-01
07506561200055BS35-XL
07506561200048BS35-L
07506561200031BS35-M
07506561200024BS25-XL
07506561200017BS25-L
07506561200000BS25-M

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