FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327198184
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ82583
Catalog number
DYNJ82583
Device description
ACL ARTHROSCOPY PACK
Published
2022-07-11
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
OIIArthrogram tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIIArthrogram TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327198184PackageGS12In Commercial Distribution
10195327198183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532719818440195327198184
1019532719818310195327198183

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
false
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
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
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50198956330854CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-26
50198956301007CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-22
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50198956253689CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-16
50198956307009CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-05
50198956291728CARDINAL HEALTHCardinal Health 200, LLCOII2025-12-31
50198956289305CARDINAL HEALTHCardinal Health 200, LLCOII2025-12-22
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50198956182989CARDINAL HEALTHCardinal Health 200, LLCOII2025-09-09
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50198956088670CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-29
50198956090628CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-29
50198956096477CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-29
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50198956076707CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-14