FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459320584
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ910159B
Catalog number
DYNJ910159B
Device description
TOTAL SHOULDER
Published
2025-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459320584PackageGS12In Commercial Distribution
10198459320583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845932058440198459320584
1019845932058310198459320583

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

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
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
10198956218611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956332096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956343139CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956395107CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956433984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956434677CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956435636CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956437883CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956440326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956446076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956453661CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956455429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956460720CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956461888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956464759CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956481565CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482166CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482425CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483279CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483620CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483835CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484764CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484887CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956487192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956488175CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08