FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327156658
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ81932
Catalog number
DYNJ81932
Device description
CYSTO PACK
Published
2022-05-08
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327156658PackageGS14In Commercial Distribution
10195327156657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532715665840195327156658
1019532715665710195327156657

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
false
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
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
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956467675CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956469280CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956488656CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956494459CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956495500CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956380455CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956431935CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956439580CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956487208CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956487826CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10080196887248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10080196926213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2025-01-19
10193489213928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2024-07-29
10080196498192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10080196498345Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-07-29
10193489211658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489212594Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213003Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489213515Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214116Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489214154Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489215472Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489216769Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2023-06-08
10193489287592Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288285Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288407Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489288414Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289749Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09
10193489289848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FDE2021-11-09