FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942505487
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA1823
Catalog number
DYNDA1823
Device description
ADULT SUTURE SET
Published
2021-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942505487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994250548710889942505487

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA 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 reusable 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
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
20809160515157MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-03-05
50198956254730CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
50198956369359CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956410815CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956377477CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
50198956318388CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
20809160509750MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-01-21
50198956325133CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
50198956201840CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956299977CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956285710CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
50198956249866CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956250053CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956192964CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
50198956199628CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956279795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956241846CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
50198956284560CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956284676CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956233520CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
50198956185126CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
50198956192889CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22
20809160494896Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-19
50198956132311CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-04
20809160493585Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-04
20809160493257Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-02
50198956170795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-19
50198956160345CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-05
50198956150131CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-28
50198956132083CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-11