FDA.reportPublic FDA data

ACS

Primary DI
00191072127372
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
ANAP22AK
Device description
A-P PACK - 205936
Published
2021-03-03
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072127372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072127372001910721273721910721273720191072127372

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
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
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