FDA.reportPublic FDA data

ACS

Primary DI
00191072174284
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
JEVH95G
Device description
LAVH
Published
2022-08-25
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
OJFHysterectomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072174284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072174284001910721742841910721742840191072174284

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10198956464643CARDINAL HEALTHCardinal Health 200, LLCOJF2026-05-25
10198956481664CARDINAL HEALTHCardinal Health 200, LLCOJF2026-05-25
50198956326826CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956401004CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956402728CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956407648CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956317527CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956376050CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956396317CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956413212CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-16
50198956402506CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-10
50198956393279CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-09
50198956220384CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956327984CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956401622CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956316612CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956320411CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956368826CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956394146CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956396980CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956335934CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956357721CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956358278CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956376524CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956380576CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956219371CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-13
50198956354256CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-13
50198956344684CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09
50198956346671CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09
50198956359398CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09