FDA.reportPublic FDA data

Aegis Personal Protective Suit

Primary DI
00872320005528
Brand
Aegis Personal Protective Suit
Company
CAO GROUP, INC.
Model
005-00082
Device description
Single use 2-piece protective suit. Extra, extra, extra, extra, extra, extra large size.
Published
2020-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00872320005559PackageGS13In Commercial Distribution
00872320005528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320005559008723200055598723200055590872320005559
00872320005528008723200055288723200055280872320005528

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, reusableA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. Depending upon its intended use, it may be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a reusable garment.

Regulatory Flags#

DUNS number
102422578
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00872320006617Picasso Pro Pre-initiated Laser Tip, Variety Pack002-004802026-04-10
00872320006846LEAP Laser Delivery Tip050832026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mm053792026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mm051932026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mm053802026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mm051942026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, Straight052212026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, Curved052222026-04-10
00872320006761Monet + Curing Laser001-001232026-02-10
00872320004477Ultimate Contour Mini005-000362019-09-06
00872320003364Pilot Diode Laser 600um Tip030932016-11-10
00872320003418Pilot Straight Tip006682016-11-10
00872320003425Pilot 60° Tip006692016-11-10
00872320003456Pilot Diode Laser030922016-11-10
00872320006457Acuity Direct X-Ray Photon Detection005-001232024-02-19
00872320006464Acuity Direct X-Ray Photon Detection005-002142024-02-19
00872320000127BlissBond Intro Kit006-00044006-000442016-11-10
00872320000141BlissEtch Intro Kit006-00029006-000292016-11-10

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Primary DI, Brand, Company table
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