FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10198459464713
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ0415920M
Catalog number
DYNJ0415920M
Device description
SINUS/EENT PACK-LF
Published
2025-08-11
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
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
40198459464714PackageGS14In Commercial Distribution
10198459464713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845946471440198459464714
1019845946471310198459464713

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956524064CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956531321CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956532885CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956534025CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956534360CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956537859CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956538665CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956540781CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956541238CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956541412CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956542464CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10809160527948HALYARDAVID MEDICAL, INC.OGR2026-07-28
10197106944028CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956371811CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956395053CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956464636CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956479975CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956483538CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956498754CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956502734CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956509207CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956510852CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956511071CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956516458CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956520691CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956523036CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956530959CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956531086CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956531314CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956531628CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27