FDA.report

Medline Industries, Inc.

Primary DI
10884389735909
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYK1014389E
Catalog number
DYK1014389E
Device description
ENDO KIT THE UNITY HOSPITAL
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

Related Records

Contact Domains

Product Codes

CodeName
NWRKit, catheter, foley (excludes hiv testing)
NWUEndoscope introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
NWRKit, catheter, foley (excludes hiv testing)
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40884389735900PackageGS120In Commercial Distribution
10884389735909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088438973590040884389735900
1088438973590910884389735909

GMDN Terms

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

Contacts

PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags

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

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10197344039845MEDLINEHNY19150HNY191502024-10-11
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10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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