FDA.reportPublic FDA data

ACS

Primary DI
00191072241764
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LLGT12F
Device description
SPINAL TRAY
Published
2026-02-19
Public version status
New
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072241764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072241764001910722417641910722417640191072241764

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
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
00191072241924ACSIHAR39AH2026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956475113CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956486362CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956491304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956518667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956554948CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956555389CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559691CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559974CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956560895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562509CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562707CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563186CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563575CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569126CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570092CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570139CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570313CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571686CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571716CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571761CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956572386CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956572485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956573147CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956573598CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956573611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10809160532812HalyardAVID MEDICAL, INC.OJG2026-09-04
10198956373105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-26