FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489295573
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ52654F
Catalog number
DYNJ52654F
Device description
ST CHARLES SHOULDER ARTHRO PK
Published
2022-06-11
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
OJHOrthopedic tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489295573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348929557310193489295573

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
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489203493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489212280Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489212549Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489212884Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213072Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213447Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213737Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213911Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213935Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489213966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214130Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214406Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214499Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489214697Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489215366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489215465Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216158Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489216752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489217117Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
10193489217711Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08