FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10198459411052
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ89819A
Catalog number
DYNJ89819A
Device description
PK CUST ROBOTIC LAP COMM
Published
2025-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459411053PackageGS13In Commercial Distribution
10198459411052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845941105340198459411053
1019845941105210198459411052

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956436626CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956465176CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956467651CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956488922CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956489691CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956493919CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956495135CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956495982CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956496125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956496132CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956496576CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956497825CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956500167CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956344471CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956404670CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956430204CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956492240CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956493155CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956494893CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-05
10198956177055CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956198456CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956461314CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956463745CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956479623CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956485280CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956489677CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956491465CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-03
10198956209220CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956452602CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01
10198956464568CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-01