FDA.reportPublic FDA data

ACS

Primary DI
00191072126115
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
AHCR00B
Device description
CRANIOTOMY PACK 178560
Published
2021-03-03
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
00191072126115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072126115001910721261151910721261150191072126115

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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
10198956376069CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956431744CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956435667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956437463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956445888CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956462342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956463486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956475625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956477087CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956484702CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956485044CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
10198956486515CARDINAL HEALTHCardinal Health 200, LLCOJG2026-05-25
50198956335569CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956359046CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956425833CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50198956427448CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-24
50197106906055CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50197106926794CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956221060CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956292541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956311020CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956313123CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956322132CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323429CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956323665CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956324198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956327106CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956329278CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334463CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23
50198956334746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-03-23