FDA.reportPublic FDA data

ACS

Primary DI
00191072155757
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
NCER17B
Device description
ER LACERATION TRAY - 170934
Published
2021-12-01
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
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072155757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072155757001910721557571910721557570191072155757

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
10198956340435CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
10198956460164CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
50198956350289CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956413991CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956418101CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-23
50198956326437CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-19
50198956350920CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-16
50198956357059CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956363333CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956387872CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956334067CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956375756CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956344813CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-13
50198956020250CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956293791CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956314557CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-02
50198956258790CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
50198956316025CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
00884450306857Performa®Merit Medical Systems, Inc.OJV2026-01-29
50198956285895CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-23
50198956263008CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956300284CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956286915CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956300406CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956203011CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301212CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301823CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-13
50198956303452CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-07
50198956292831CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05
50198956305487CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05