FDA.reportPublic FDA data

ACS

Primary DI
00191072195036
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
MTBR78A
Device description
MAJOR BURN PACK
Published
2023-05-01
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
OJJBurn kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072195036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072195036001910721950361910721950360191072195036

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
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
50198956430189CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-24
00766588260051Burn Dressing Small - Red Velcro BagCertified Safety Manufacturing, Inc.OJJ2026-03-23
50198956399035CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-19
50198956413670CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-16
50198956413199CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-10
50198956328257CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-13
50198956360769CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-09
M689SBK1200000030BurnFree Burn Kit 10/CaseSafeguard US Operating, LLCOJJ2026-02-05
50198956306262CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-02
50198956270235CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-01-13
50198956307207CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-01-05
50198956254853CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-12-10
50198956251296CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-12-02
50198956217834CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-28
50198956267310CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-28
50198956264166CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-25
50198956218237CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956256567CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956258523CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956259599CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-11
50198956194128CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-09-18
50198956183436CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-09-03
50198956142297CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-28
50198956092028CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-08
50198956153514CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-05
M689FSKHA00020First Responder Food Service Burn Kit 5/CaseSafeguard US Operating, LLCOJJ2025-07-30
40198459418632MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJJ2025-07-21
50198956137811CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-07-03
50197106928712CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-06-30
50198956119756CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-06-23