FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10080196194902
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYK1004288M1
Catalog number
DYK1004288M1
Device description
LOWER FLORIDA KEYS MAT KIT
Published
2021-07-16
Public version status
Update
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196194903PackageGS16In Commercial Distribution
10080196194902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019619490340080196194903
1008019619490210080196194902

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956388208CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-09
10809160526927HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526941HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526842HalyardAVID MEDICAL, INC.OKV2026-07-08
10809160526811HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526828HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526507HalyardAVID MEDICAL, INC.OKV2026-07-06
10809160526309HalyardAVID MEDICAL, INC.OKV2026-06-26
10809160525951HalyardAVID MEDICAL, INC.OKV2026-06-24
10198956485075CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-23
10809160525203HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525258HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525265HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525326HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525500HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525593HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525654HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160523087HalyardAVID MEDICAL, INC.OKV2026-06-09
10809160523117HalyardAVID MEDICAL, INC.OKV2026-06-09
10198956454101CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-08
10809160522837HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522851HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522868HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522882HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522974HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522998HalyardAVID MEDICAL, INC.OKV2026-06-08
10198956445000CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-05
10809160522776HalyardAVID MEDICAL, INC.OKV2026-06-05
10809160522424HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522431HalyardAVID MEDICAL, INC.OKV2026-06-02