FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489688222
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DNSC83499B
Catalog number
DNSC83499B
Device description
NDL INTRO 18G X 7CM
Published
2022-08-04
Public version status
New
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489688222PackageGS1500In Commercial Distribution
10193489688221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348968822240193489688222
1019348968822110193489688221

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.

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
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08022057015747JOSEPH LAMELAS Atrial Lift SystemCORCYM SRLDWS2026-02-03
08022057015754CUFF Aortic Root Exposure DeviceCORCYM SRLDWS2026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerCORCYM SRLDWS2026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLDWS2026-02-03
08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
G4533324301300PEAK MEDICALPeak Medical Distribution Inc.DWS2024-09-17
G586NS30105710Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G586NSCV511010Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G45352745404BC0PEAK MEDICALPeak Medical Distribution Inc.DWS2024-02-01
07898506818204QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818211QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818198QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506818228QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853106QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853113QuinelatoSchobell Industrial LtdaDWS2023-01-09
07899798203846QuinelatoSchobell Industrial LtdaDWS2022-12-16
ESOT001241NAS & T AGDWS2022-09-15
ESOT001251NAS & T AGDWS2022-09-15
ESOT002331NAS & T AGDWS2022-09-15
ESOT002481NAS & T AGDWS2022-09-15
ESOT002491NAS & T AGDWS2022-09-15
ESOT002501NAS & T AGDWS2022-09-15
ESOT002751NAS & T AGDWS2022-09-15
ESOT002761NAS & T AGDWS2022-09-15
ESOT003241NAS & T AGDWS2022-09-15
ESOT005011NAS & T AGDWS2022-09-15
ESOT005431NAS & T AGDWS2022-09-15
ESOT005741NAS & T AGDWS2022-09-15
ESOT005771NAS & T AGDWS2022-09-15
ESOT005881NAS & T AGDWS2022-09-15