FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942114764
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
P130825
Catalog number
P130825
Device description
BIAS STCKNT 4 KIT
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112769000CURAD COMPRESSION HOSIERYMedline Industries, Inc.2012-03-01DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942114764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994211476410889942114764

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA 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 reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196299850MEDLINEMSC9614EPMSC9614EP2026-10-22
10193489109702NAMICDYNJCAPMF1DYNJCAPMF12026-10-22
10884389119310MEDLINEMSC1513MSC15132026-10-22
10080196317462MEDLINEMSC1510MSC15102026-10-21
10884389111499MEDLINEMSC1528MSC15282026-10-21
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08300496073895SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
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08300496073918SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073925SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073932SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073949SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073956SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073963SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073970SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073987SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073994SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074007SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074014SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074021SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074038SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074045SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074052SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074069SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074076SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074083SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074090SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074106SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074113SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074120SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074137SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074144SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074151SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074168SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074175SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16