FDA.reportPublic FDA data

ACS

Primary DI
00191072209795
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
SLAK19A
Device description
NON-STERILE ANESTHESIA KIT
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072209795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072209795001910722097951910722097950191072209795

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

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
false

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
04048223128534StimuLong Sono II NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-07-30
04048223129456EpiLong TuohyPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133385EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133392EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223128190SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128206SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128244StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128312SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128343PlexoLong NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128398SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128404SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128435PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128527SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128558StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128565SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128589SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128596SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128602SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128626PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128633StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128640SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128664SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128688SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128701SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128725StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128749StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128756StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128763StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128787StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128800StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17