FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489856187
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ45717C
Catalog number
DYNJ45717C
Device description
SPINE PACK
Published
2021-06-02
Public version status
Update
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
40193489856188PackageGS13In Commercial Distribution
10193489856187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348985618840193489856188
1019348985618710193489856187

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
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196321445MEDLINEMDS30804MDS308042026-09-24
30080196293548MEDLINENON28625NON286252026-09-24
40080196921554GeminiGEM5172GEM51722016-10-14
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10080196632381MEDLINE INDUSTRIES, INC.MSC7344EPMSC7344EP2021-05-18
10193489104516MEDLINEMRPP2910MRPP29102024-07-11
10884389931943MEDLINE INDUSTRIES, INC.MSC7318EPMSC7318EP2021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196184085GeminiGEM3118SGEM3118S2016-10-14
20080196184283GeminiGEM3130SGEM3130S2016-10-14
20080196184344GeminiGEM3136SGEM3136S2016-10-14
20080196184498GeminiGEM3140SGEM3140S2016-10-14
20080196184559GeminiGEM3145SGEM3145S2016-10-14
20080196184610GeminiGEM3148SGEM3148S2016-10-14
20080196184696GeminiGEM3154SGEM3154S2016-10-14
20080196184986GeminiGEM4118SGEM4118S2020-12-22
20080196921185GeminiGEM1148GEM11482016-10-14
20080196921192GeminiGEM1154GEM11542016-10-14
20080196921307GeminiGEM3118GEM31182016-10-14
20080196921321GeminiGEM3124GEM31242016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556839690Total Foot System 2Smith & Nephew, Inc.OJH2026-09-24
00885556839706Total Foot System 2Smith & Nephew, Inc.OJH2026-09-24
00885556859636Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859643Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859650Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859698Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859704Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859711Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859728Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859735Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859742Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859759Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859766Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859773Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859780Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859797Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859803Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
10198956362550CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956415607CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956462984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956502468CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956507654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956513365CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956520257CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956533264CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956538214CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956545618CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956545687CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956552005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956552203CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22