FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459326227
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ911344
Catalog number
DYNJ911344
Device description
PELVISCOPY KIT
Published
2025-04-18
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
MLTPelvic exam kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459326227PackageGS12In Commercial Distribution
10198459326226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845932622740198459326227
1019845932622610198459326226

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
50198956327328CARDINAL HEALTHCardinal Health 200, LLCMLT2026-03-09
50198956270273CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
50198956273533CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
00653160388985MEDLINEMEDLINE INDUSTRIES, INC.MLT2025-08-02
40198459445218MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-28
40198459383749MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
40198459389208MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
40198459363727MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-09
40198459351748MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-02
50198956037647CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
40198459323714Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
40198459325138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459312953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
40198459315818Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
50198956019087CARDINAL HEALTHCardinal Health 200, LLCMLT2025-04-03
50197106946365CARDINAL HEALTHCardinal Health 200, LLCMLT2025-03-17
40198459273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-03-02
40198459268725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-23
50197106952083CARDINAL HEALTHCardinal Health 200, LLCMLT2025-02-17
10198459260889Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-16
40198459257026Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-09
50197106921027CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-28
50197106641222CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
50197106899838CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
40198459222048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
40198459225568Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
40198459200763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-01
40198459192464Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-24
40198459173227Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17
40198459174378Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17