FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
40198459342067
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ82107A
Catalog number
DYNJ82107A
Device description
EYE PACK
Published
2025-05-12
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
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459342067PackageGS18In Commercial Distribution
10198459342066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845934206740198459342067
1019845934206610198459342066

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
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956227552CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956418899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956477551CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956489264CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956498556CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956501911CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956470507CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956490260CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956491960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956492776CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493001CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493377CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956495173CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956496569CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956499744CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956397682CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956417229CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956478992CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956487642CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10197106817643CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956351738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956407084CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956410145CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956418387CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421219CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956439559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01