FDA.reportPublic FDA data

ACS

Primary DI
00191072099860
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LLCR99G
Device description
ADULT CRANIOTOMY PACK
Published
2020-03-17
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072099860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072099860001910720998601910720998600191072099860

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
10198956543577CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956572287CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956592230CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956603240CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956604025CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956493803CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956542174CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956556423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956561304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956568105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956571211CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956573277CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956578746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956594289CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956598294CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600140CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601109CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601192CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601406CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601741CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956602045CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10809160540190HalyardAVID MEDICAL, INC.OJG2026-10-08
10198956141018CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956314351CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956458925CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541627CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956544918CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06