FDA.report

ACS

Primary DI
00191072155641
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
EMPI18E
Device description
PORT INSERTION TRAY - 170264
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

Related Records

Product Codes

CodeName
OKEPort introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072155641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072155641001910721556411910721556410191072155641

GMDN Terms

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
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

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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 DIBrandCompanyProduct codePublished
50198956293159CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956420708CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956424478CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956412321CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-19
50198956328134CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-10
50198956322194CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956339741CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956363531CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956401011CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956375688CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956377095CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956398625CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956336023CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359060CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359770CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956380446CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956323030CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956333992CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956344530CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956338096CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-17
50198956323115CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-13
50198956322682CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956333626CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956335200CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956356243CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956341591CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-30
50198956306118CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-23
50198956258585CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-22
00191072241610ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14
00191072241634ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14