FDA.reportPublic FDA data

ACS

Primary DI
00191072164377
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
NLCI24A
Device description
CIRCUMCISION TRAY
Published
2022-03-21
Public version status
Update
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
OHGCircumcision tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072164377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072164377001910721643771910721643770191072164377

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
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
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10197106963036CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-02
10197106988534CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-11
10197106988848CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-03
10197106990711CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-03
10197106990469CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-01
10197106983300CARDINAL HEALTHCardinal Health 200, LLCOHG2025-03-21
10197106963821CARDINAL HEALTHCardinal Health 200, LLCOHG2025-03-06
10197106920909CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-21
10197106556177CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106919798CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106881255CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-13
10198459240317Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHG2025-01-19
10197106824412CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-15
10197106846117CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-14
10197106864937CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-11
10197106765364CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-04
10197106829028CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-26
10197106807903CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-25
10197106803172CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106819746CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106780510CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-08
10197106791189CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-31
10197106795729CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-11
10197106739754CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-01
10197106661765CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-27
10197106755952CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-09
10197106732694CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-06