FDA.report

ACS

Primary DI
00191072107237
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
UISL02B
Device description
STERILE "STERILE WATER" LABEL KIT
Published
2020-04-06
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
LYVLABEL OR TAG, STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191072107237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072107237001910721072371910721072370191072107237

GMDN Terms

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
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
B050SL1000021Sterile LabelsTYPENEX MEDICAL LLCLYV2026-03-17
17540277009646PharmaTagsRMAC Surgical, IncLYV2026-03-12
17540277009639PharmaTagsRMAC Surgical, IncLYV2026-03-03
17540277000001PharmaTagsRMAC Surgical, IncLYV2026-02-06
10754027700104PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700111PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700142PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700173PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700265PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700715PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700722PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700739PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700746PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700753PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700777PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700784PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700791PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700807PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700814PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700821PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700838PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700845PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700852PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700869PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700876PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700883PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700890PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700906PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700913PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700920PharmaTagsRMAC Surgical, IncLYV2026-02-02