FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489418057
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJRA1657A
Catalog number
DYNJRA1657A
Device description
DR HOELL PAIN TRAY
Published
2023-06-08
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
OFTSpinal epidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489418058PackageGS130In Commercial Distribution
10193489418057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348941805840193489418058
1019348941805710193489418057

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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
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
10193489437966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-07-29
10193489211931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489213485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214468Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215373Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215878Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489216233Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489412222Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489413717Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489417821Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489419092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422313Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422344Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489423396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425277Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489429909Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489441420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489441604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445398Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445527Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445572Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08