FDA.report

ACS

Primary DI
00191072128805
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
OSHY47C
Device description
HYSTEROSCOPY PACK 176527
Published
2021-11-29
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
OHDGynecological laparoscopic kit

Product Code Classifications

CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072128805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072128805001910721288051910721288050191072128805

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

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
50198956314687CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956374148CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956382433CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956399301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956418194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425611CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956258257CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956343243CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956350708CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956353273CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956370270CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956386868CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956389487CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956392401CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956416909CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956419979CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956420555CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956420920CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956431988CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956218763CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956218824CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956259704CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956325362CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956327137CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956334029CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956341607CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956350869CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956364958CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956383010CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19