FDA.reportPublic FDA data

Advance Plus™ Earloop Procedure Masks

Primary DI
20810012650032
Brand
Advance Plus™ Earloop Procedure Masks
Company
SOUTHERN ANESTHESIA & SURGICAL, INC.
Model
ADV2316
Catalog number
ADV2316
Device description
Earloop Procedure Masks, ASTM Level 3, Blue, Box
Published
2020-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810012650032PackageGS110In Commercial Distribution
10810012650035PrimaryGS10
00810012650038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081001265003220810012650032
1081001265003510810012650035
00810012650038008100126500388100126500380810012650038

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119186732
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810012650083Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23292020-05-28
00810012650090Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23302020-05-28
00810012650106Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23312020-05-28
00810012650113Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23322020-05-28
00810012650120Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23292020-05-28
00810012650137Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23302020-05-28
00810012650144Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23312020-05-28
00810012650151Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23322020-05-28
10810012650165Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23192020-05-28
10810012650172Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23202020-05-28
10810012650189Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23212020-05-28
10810012650196Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23222020-05-28
10810012650202Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23232020-05-28
10810012650219Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23242020-06-04
10810012650226Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23252020-06-04
10810012650233Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23262020-06-04
10810012650240Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23272020-06-04
10810012650257Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23282020-06-04
20810012650216Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23242020-06-04
20810012650223Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23252020-06-04

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