FDA.reportPublic FDA data

ACS

Primary DI
00191072241689
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
LMTF30M
Device description
TRANSFORAMINAL TRAY
Published
2026-01-14
Public version status
New
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
OGEEpidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072241689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072241689001910722416891910722416890191072241689

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
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
10198956576131CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-19
10198956607644CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-19
04046955966295Design Options®B. BRAUN MEDICAL INC.OGE2026-10-18
10198956563056CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956568969CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956604650CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956604902CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-15
10198956578753CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-13
10198956545274CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-12
10198956589827CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-12
10198956579866CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-06
10198956588844CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-06
10198956563087CARDINAL HEALTHCardinal Health 200, LLCOGE2026-10-01
10198956580138CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-30
10198956545946CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956566910CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956569386CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
10198956575615CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-29
B098AMS195170Aligned Medical SolutionsAligned Medical SolutionsOGE2026-09-26
10198956565982CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956586543CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956590724CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-25
10198956550377CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-21
10198956542853CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956560369CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956561847CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956563155CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564343CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956564619CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04
10198956565227CARDINAL HEALTHCardinal Health 200, LLCOGE2026-09-04