FDA.reportPublic FDA data

Defend

Primary DI
90816577021651
Brand
Defend
Company
YOUNG MYDENT, LLC
Model
SG-3660PPL
Device description
DEFEND PLUS LAB COAT PURPLE LARGE
Published
2016-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90816577021651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9081657702165190816577021651

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081330555
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90816577020395DefendVP-90032016-11-11
90816577020401DefendVP-90082016-11-11
90816577020425DefendMK-71002016-11-03
90816577020449DefendMK-71102016-11-03
90816577020463DefendMK-71202016-11-03
90816577020487DefendMK-72002016-11-07
90816577020500DefendMK-72102016-11-07
90816577020524DefendMK-72202016-11-07
90816577020548DefendMK-73002017-02-02
90816577020562DefendMK-73102016-11-07
90816577020586DefendMK-73202016-11-07
90816577020609DefendMK-74002016-10-26
90816577020623DefendVP-80082016-11-11
90816577020630DefendVP-80062016-11-11
90816577020647DefendVP-90112016-11-11
90816577020654DefendVP-90072016-11-11
90816577020661DefendVP-90102016-11-11
90816577020678DefendVP-90052016-11-11
90816577020685DefendVP-90092016-11-11
90816577020692DefendVP-90042016-11-11

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Primary DI, Brand, Company table
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00842942016080PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524410PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524441PRIMEDpriMED Medical Products IncFME2025-07-15
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
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10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
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10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
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10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15