FDA.report

ACS

Primary DI
00191072136992
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SVMN60I
Device description
MINOR CV TRAY 153433
Published
2021-08-10
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
OEZCardiovascular procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072136992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072136992001910721369921910721369920191072136992

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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00191072241986ACSLKTH15W2026-03-24
00191072241993ACSFDTH08AJ2026-03-24
00191072242006ACSFDTK07AH2026-03-24
00191072242013ACSFDKA44S2026-03-24
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00191072241856ACSRGLC12P2026-02-19
00191072241863ACSUIHN18AZ2026-02-19
00191072241870ACSBDAG39C2026-02-19
00191072241887ACSIHTK48AO2026-02-19
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00191072241900ACSUICA66AS2026-02-19
00191072241917ACSMWTK13AI2026-02-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00191072241948ACSAMERICAN CONTRACT SYSTEMS, INC.OEZ2026-03-24
00191072241962ACSAMERICAN CONTRACT SYSTEMS, INC.OEZ2026-03-24
10884450111731Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
10884450423629Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
20884450430815Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
10884450430863Merit Medical®Merit Medical Systems, Inc.OEZ2026-03-24
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