FDA.reportPublic FDA data

ACS

Primary DI
00191072017574
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UMEA16A
Device description
EAR PACK 175620
Published
2020-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072017574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072017574001910720175741910720175740191072017574

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
010334675
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191072241948ACSAMMV04AE2026-03-24
00191072241962ACSFDCR00AE2026-03-24
00191072241979ACSLKTK16AB2026-03-24
00191072241986ACSLKTH15W2026-03-24
00191072241993ACSFDTH08AJ2026-03-24
00191072242006ACSFDTK07AH2026-03-24
00191072242013ACSFDKA44S2026-03-24
00191072242020ACSFDSA15N2026-03-24
00191072242037ACSBPHA89E2026-03-24
00191072241757ACSSPSA58S2026-02-19
00191072241764ACSLLGT12F2026-02-19
00191072241801ACSCIEY01G2026-02-19
00191072241818ACSWEHF12B2026-02-19
00191072241856ACSRGLC12P2026-02-19
00191072241863ACSUIHN18AZ2026-02-19
00191072241870ACSBDAG39C2026-02-19
00191072241887ACSIHTK48AO2026-02-19
00191072241894ACSIHTR90N2026-02-19
00191072241900ACSUICA66AS2026-02-19
00191072241917ACSMWTK13AI2026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956435858CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443761CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443815CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443839CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956503243CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956503403CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956505421CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956505698CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956506671CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956508200CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956513440CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514034CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514072CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514584CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956516557CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956520189CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956523012CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956525689CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956526426CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956528031CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956528703CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956529267CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530539CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530553CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956531352CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20