FDA.reportPublic FDA data

ACS

Primary DI
00191072215475
Brand
ACS
Company
AMERICAN CONTRACT SYSTEMS, INC.
Model
BPMY56C
Device description
MYRINGOTOMY WOLFSON PACK BHS
Published
2024-01-12
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
OGSMyringotomy procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191072215475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191072215475001910722154751910722154750191072215475

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
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956060447CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956021318CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-11
50197106824151CARDINAL HEALTHCardinal Health 200, LLCOGS2024-11-06
50197106783168CARDINAL HEALTHCardinal Health 200, LLCOGS2024-10-14
50197106795246CARDINAL HEALTHCardinal Health 200, LLCOGS2024-10-07
50197106766222CARDINAL HEALTHCardinal Health 200, LLCOGS2024-09-09
50197106739936CARDINAL HEALTHCardinal Health 200, LLCOGS2024-09-03
50197106757312CARDINAL HEALTHCardinal Health 200, LLCOGS2024-08-30
00840183527730BR Surgical, LLCBR Surgical, LLCOGS2024-08-09
00840183512941BR Surgical, LLCBR Surgical, LLCOGS2024-07-23
50197106708277CARDINAL HEALTHCardinal Health 200, LLCOGS2024-07-09
50197106616855CARDINAL HEALTHCardinal Health 200, LLCOGS2024-05-16
50197106657803CARDINAL HEALTHCardinal Health 200, LLCOGS2024-05-16
50197106585939CARDINAL HEALTHCardinal Health 200, LLCOGS2024-03-21
50197106592753CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-29
50197106549252CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-27