FDA.reportPublic FDA data

ACS

Primary DI
00191072084729
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIDE21W
Device description
DENTISTRY EXTRACTION (PS 065559)
Published
2020-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFXGeneral purpose dental tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072084729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072084729001910720847291910720847290191072084729

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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
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
10198956487093CARDINAL HEALTHCardinal Health 200, LLCOFX2026-05-25
50198956366891CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-23
50198956321296CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-19
50198956351705CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956351743CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956214741CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-09
50198956355024CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-06
50198956334357CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336641CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336627CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956386998CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956177091CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366457CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366884CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-13
50198956285253CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956345179CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956199673CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-30
50197106904334CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-23
50198956103137CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-05
50198956267006CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-31
50198956288452CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-17
50198956210057CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-10
50198956217704CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956285031CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956277593CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-28
50198956281576CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-25
50198956259179CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956266986CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956273199CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956158120CARDINAL HEALTHCardinal Health 200, LLCOFX2025-09-29