FDA.reportPublic FDA data

ACS

Primary DI
00191072116864
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UIDL01H
Device description
SFCH DIRECT LARYNGOSCOPY (PS 107026)
Published
2020-09-24
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
OGHLaryngoscope kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGHLaryngoscope KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072116864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072116864001910721168641910721168640191072116864

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile 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
10198956377196CARDINAL HEALTHCardinal Health 200, LLCOGH2026-03-31
10198956330627CARDINAL HEALTHCardinal Health 200, LLCOGH2026-02-09
50198956330625CARDINAL HEALTHCardinal Health 200, LLCOGH2026-02-09
05707480163205Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163267Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
05707480163212Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163274Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
10197106816394CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
50197106816392CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
10197106728970CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
50197106728978CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
10197106314395CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
50197106314393CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
10197106409015CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
50197106409013CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
00191072194480ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2023-05-01
00810094575588CuraplexBOUND TREE MEDICAL, LLCOGH2023-03-30
00612649181264Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
00612649178073King Vision Video Laryngoscope KitKing Systems CorporationOGH2022-12-08
00612649182100Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
10195594579692CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
50195594579690CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
10195594552435CARDINAL HEALTHCardinal Health 200, LLCOGH2022-03-23
50195594552433CARDINAL HEALTHCardinal Health 200, LLCOGH2022-03-23
10195594544676CARDINAL HEALTHCardinal Health 200, LLCOGH2022-02-26
50195594544674CARDINAL HEALTHCardinal Health 200, LLCOGH2022-02-26
10888439932447CARDINAL HEALTHCardinal Health 200, LLCOGH2021-10-07
50888439932445CARDINAL HEALTHCardinal Health 200, LLCOGH2021-10-07
10195594321871CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-16
50195594321879CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-16