FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10198459375637
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA3192A
Catalog number
DYNDA3192A
Device description
MCDONALD SUTURE PACK
Published
2025-06-16
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
PKDLaceration tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKDLaceration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459375638PackageGS118In Commercial Distribution
10198459375637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845937563840198459375638
1019845937563710198459375637

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956193611CARDINAL HEALTHCardinal Health 200, LLCPKD2026-02-17
10198956269521CARDINAL HEALTHCardinal Health 200, LLCPKD2026-01-15
10198956272422CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-19
10198956258549CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-11
10198956274327CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-09
10198956281493CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-09
10198956161832CARDINAL HEALTHCardinal Health 200, LLCPKD2025-11-25
10198459475177MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-18
10198459467455MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-11
10198459426209MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-04
10198459437960MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-04
10198459350924MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459424427MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459437854MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459440311MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459442155MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459432422MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-21
10198459432590MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-21
10198956099371CARDINAL HEALTHCardinal Health 200, LLCPKD2025-07-21
10198459400230MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-07
10198459389337MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-02
10198459391613MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-02
10198956104181CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-26
10198459333491MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459369735MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459370199MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459379086MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198956042117CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-11
10198956071797CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-09
10198459333187MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-05-02