FDA.report

ACS

Primary DI
00191072134752
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
BLJT19A
Device description
JOINT TRAY
Published
2021-05-10
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
OIPRadiology-diagnostic kit

Product Code Classifications

CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072134752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072134752001910721347521910721347520191072134752

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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00191072241979ACSLKTK16AB2026-03-24
00191072241986ACSLKTH15W2026-03-24
00191072241993ACSFDTH08AJ2026-03-24
00191072242006ACSFDTK07AH2026-03-24
00191072242013ACSFDKA44S2026-03-24
00191072242020ACSFDSA15N2026-03-24
00191072242037ACSBPHA89E2026-03-24
00191072241757ACSSPSA58S2026-02-19
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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

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Primary DIBrandCompanyProduct codePublished
00191072242037ACSAMERICAN CONTRACT SYSTEMS, INC.OIP2026-03-24
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50198956377279CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
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50198956386691CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956335613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956368710CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956297843CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-20
50198956322613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956330847CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956167566CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956324075CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956325935CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956345001CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956334920CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-29