FDA.reportPublic FDA data

ACS

Primary DI
00191072123268
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SPOB12G
Device description
OB DELIVERY PACK
Published
2021-02-17
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072123268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072123268001910721232681910721232680191072123268

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
10198956449114CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956453258CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956472501CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956476196CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956488663CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
10198956488700CARDINAL HEALTHCardinal Health 200, LLCMLS2026-05-25
50198956420531CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956421040CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956417753CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956419818CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420760CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956427820CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956310092CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956393774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956407365CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956408805CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956413946CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956318609CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956401363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956414950CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956418774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956278064CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956313925CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408706CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408959CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411416CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411775CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956366099CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09