FDA.reportPublic FDA data

MEDLINE

Primary DI
10889942219889
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
P155615A
Catalog number
P155615A
Device description
MYELOGRAM PACK
Published
2016-11-07
Public version status
Update
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942219880PackageGS120In Commercial Distribution
10889942219889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994221988040889942219880
1088994221988910889942219889

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

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
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528518HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528525HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528532HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528549HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528556HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528570HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528594HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528617HalyardAVID MEDICAL, INC.LRO2026-08-03
10885632528620SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-03
B098AMS16817B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS17579A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS178970Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
B098AMS191170Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-03
10809160528341HALYARDAVID MEDICAL, INC.LRO2026-08-01
10198956352315CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956364998CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956395503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956453180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31
10198956485358CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-31