FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489405423
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ46561L
Catalog number
DYNJ46561L
Device description
F-GYN LAPAROSCOPY PACK
Published
2021-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
40193489405423PackageGS12In Commercial Distribution
10193489405422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348940542340193489405423
1019348940542210193489405422

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10080196144310MEDLINEDYNDX51813DYNDX518132026-06-08
10884389123997MEDLINEDYNDX50251DYNDX502512026-06-08
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11

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