FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489361193
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ55955B
Catalog number
DYNJ55955B
Device description
RHINO/SEPTO/FESS PACK
Published
2022-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
10193489361193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348936119310193489361193

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
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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