FDA.reportPublic FDA data

AMXOR Tray Covers

Primary DI
00850049248358
Brand
AMXOR Tray Covers
Company
Amxor Healthcare LLC
Model
ATC-B
Device description
"AMXOR Tray Covers, Non-Sterile, Rounded Corners, 8 1.2"" x 12 1/2"", Blue"
Published
2024-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049248358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049248358008500492483588500492483580850049248358

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray cover, single-useA flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7867861207e.colon@amxorhealthcare.com

Regulatory Flags#

DUNS number
124112849
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049248075AMXOR Imperative 3-Layer SMS JacketAJ-PKS2024-03-13
00850049248099AMXOR Imperative 3-Layer SMS JacketAJ-PPS2024-03-13
00850049248112AMXOR Imperative 3-Layers SMS JacketAJ-CBS2024-03-13
00850049248136AMXOR Imperative 3-Layer SMS JacketAJ-PKM2024-03-13
00850049248150AMXOR Imperative 3-Layer SMS JacketAJ-PPM2024-03-13
00850049248174AMXOR Imperative 3-Layer SMS JacketAJ-CBM2024-03-13
00850049248198AMXOR Imperative 3-Layer SMS JacketAJ-PKL2024-03-13
00850049248211AMXOR Imperative 3-Layer SMS JacketAJ-PPL2024-03-13
00850049248235AMXOR Imperative 3-Layer SMS JacketAJ-CBL2024-03-13
00850049248259AMXOR Imperative 3-Layer SMS JacketAJ-PKXL2024-03-13
00850049248273AMXOR Imperative 3-Layer SMS JacketAJ-PPXL2024-03-13
00850049248297AMXOR Imperative 3-Layer SMS JacketAJ-CBXL2024-03-13
00850049248082AMXOR Imperative 3-Layer SMS JacketAJ-PKS2024-03-13
00850049248105AMXOR Imperative 3-Layer SMS JacketAJ-PPS2024-03-13
00850049248129AMXOR Imperative 3-Layers SMS JacketAJ-CBS2024-03-13
00850049248143AMXOR Imperative 3-Layer SMS JacketAJ-PKM2024-03-13
00850049248167AMXOR Imperative 3-Layer SMS JacketAJ-PPM2024-03-13
00850049248181AMXOR Imperative 3-Layer SMS JacketAJ-CBM2024-03-13
00850049248204AMXOR Imperative 3-Layer SMS JacketAJ-PKL2024-03-13
00850049248228AMXOR Imperative 3-Layer SMS JacketAJ-PPL2024-03-13

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Primary DI, Brand, Company table
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10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
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