FDA.report

Medline Industries, Inc.

Primary DI
10195327256456
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ908446B
Catalog number
DYNJ908446B
Device description
PELVISCOPY
Published
2022-11-23
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

Related Records

Contact Domains

Product Codes

CodeName
MLTPelvic exam kit

Product Code Classifications

CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10195327256456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019532725645610195327256456

GMDN Terms

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

Contacts

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 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 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
40198459326227Medline 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