FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489451482
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ901852C
Catalog number
DYNJ901852C
Device description
LOU MINOR ENT
Published
2023-06-08
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
MMOTRAY, SURGICAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489451482PackageGS13In Commercial Distribution
10193489451481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348945148240193489451482
1019348945148110193489451481

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
true
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
14250368861734Tray TTP-VARIACHeinz Kurz GmbHMMO2026-05-21
14250368861741Tray KURZ MeterHeinz Kurz GmbHMMO2026-05-21
14250368861765Tray Cartilage PunchHeinz Kurz GmbHMMO2026-05-21
00757770403929Bausch + LombBausch & Lomb IncorporatedMMO2026-04-30
10889483563441BALLARD™SUNMED, LLCMMO2026-01-12
04250676747204Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747211Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747235Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747228Tray setSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993600128Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601927Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601934Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
00840217910033Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
00840217910040Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
00840217910057Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
04250676741554Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741561Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741578Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741585Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741592Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741608Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741622Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741639Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741899Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250407778262FENTEXFENTEX medical GmbHMMO2025-02-19
00840217909396Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
00840217909402Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
10198459084775Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
40198459084776Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
00848253002347InHealth Technologies; Blom-SingerFreudenberg Medical, LLCMMO2023-11-03