FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10198459368028
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ907206G
Catalog number
DYNJ907206G
Device description
WMC COCHLEAR IMPLANT ADD ON
Published
2025-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459368029PackageGS12In Commercial Distribution
10198459368028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845936802940198459368029
1019845936802810198459368028

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
10193489024517MEDLINEMDS601LSQHFEMDS601LSQHFE2026-07-22
10888277348141MEDLINEMDS601P2MDS601P22026-07-22
10884389145517MEDLINEMDS630BSQMDS630BSQ2016-09-27
10884389145722MEDLINEMDS630LSQMDS630LSQ2016-10-14
10884389145739MEDLINEMDS630MSQMDS630MSQ2016-10-14
10884389818794MEDLINEMDS630XSQMDS630XSQ2016-09-27
20080196162410MEDLINEMPHADJDEPTH2MPHADJDEPTH22023-01-21
10080196395811MEDLINEMPH100030MPH1000302026-07-22
10653160393979MEDLINEDYNDC3596DYNDC35962026-07-21
10653160394051MEDLINEDYNDC3606DYNDC36062026-07-21
10653160394082MEDLINEDYNDC3613DYNDC36132026-07-21
10653160394099MEDLINEIV8880AIV8880A2026-07-21
10653160394105MEDLINEECVC8651ECVC86512026-07-21
10653160394112MEDLINEDYNDC3597DYNDC35972026-07-21
10653160394129MEDLINEDYNDC3611DYNDC36112026-07-21
10653160394150MEDLINEDYNDJ1156DYNDJ11562026-07-21
10653160394167MEDLINEDYNDV2742ADYNDV2742A2026-07-21
10653160394174MEDLINEECVC8390CECVC8390C2026-07-21
10653160394181MEDLINEEBSI1477CEBSI1477C2026-07-21
10653160394211MEDLINEDYNDC3605DYNDC36052026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956443839CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
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10198956503403CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956505421CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
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10198956508200CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
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10198956529267CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530539CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530553CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956531352CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20