FDA.reportPublic FDA data

ACS

Primary DI
00191072145277
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SLDT17K
Device description
DAVINCI TRAY
Published
2021-08-25
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072145277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072145277001910721452771910721452770191072145277

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
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10198956482227CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-05-25
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50198956318999CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956323108CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956343366CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956379815CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956382235CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956382396CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956409666CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956425321CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956220704CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956316797CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956331844CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956258530CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956377828CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956385007CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956400977CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956285451CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956369854CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956390650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956329582CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956343113CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956348941CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956359787CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956395365CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956350104CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956364866CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956369380CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956390933CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06