FDA.reportPublic FDA data

Edge™ EarLoop Procedure Masks

Primary DI
10818365020949
Brand
Edge™ EarLoop Procedure Masks
Company
EDGE ENDO LLC
Model
5722008
Catalog number
5722008
Device description
Earloop Procedure Masks, ASTM Level 1, Pink, Box
Published
2020-02-06
Public version status
Update
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
FXXMask, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20818365020946PackageGS110In Commercial Distribution
10818365020949PrimaryGS10
00818365020942Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081836502094620818365020946
1081836502094910818365020949
00818365020942008183650209428183650209420818365020942

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
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078474365
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818365021031EdgeTemp™ Plus Hydraulic Temporary Restorative MaterialETEMPPLUS2020-08-28
00818365020027EdgeTemp Hydraulic Temporary RestorativeEETEMP2017-01-25
D858EETEMP0LEdgeTemp Hydraulic Temporary RestorativeEETEMP2017-02-12
D858EETEMP1230EdgeTemp Hydraulic Temporary RestorativeEETEMP2017-02-11
10818365020994Edge™ EarLoop Procedure Masks572201757220172020-02-06
10818365021014Edge™ EarLoop Procedure Masks572201657220162020-02-06
10818365020932Edge™ EarLoop Procedure Masks”572200957220092020-02-06
10818365020956Edge™ EarLoop Procedure Masks572200657220062020-02-06
10818365020963Edge™ EarLoop Procedure Masks572235257223522020-02-06
10818365020970Edge™ EarLoop Procedure Masks572201357220132020-02-06
10818365020987Edge™ EarLoop Procedure Masks572201157220112020-02-06
20818365020991Edge™ EarLoop Procedure Masks572201757220172020-02-06
10818365021007Edge™ EarLoop Procedure Masks572201557220152020-02-06
20818365021011Edge™ EarLoop Procedure Masks572201657220162020-02-06
00818365020096EdgeSurgicalTip™ #1AS3D12018-06-10
00818365020102EdgeSurgicalTip™ #2AS3D22018-06-10
00818365020119EdgeSurgical Tip™ #3P15LD2018-06-10
00818365020126EdgeSurgicalTip™ #4ASLD2018-06-10
00818365020133EdgeSurgicalTip™ #5P15RD2018-06-10
00818365020140EdgeSurgicalTip™ #6ASRD2018-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05