FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459202675
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ61752F
Catalog number
DYNJ61752F
Device description
PRISMA C-SECTION PACK
Published
2024-12-08
Public version status
New
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459202675PackageGS12In Commercial Distribution
10198459202674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845920267540198459202675
1019845920267410198459202674

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
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956312920CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956482203CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956495234CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956497832CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956498129CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956499249CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956231061CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956453227CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956466029CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956487239CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956489370CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956491984CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956493964CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956496323CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956467378CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956488120CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956489523CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956490444CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956490918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956460614CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956462250CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956480056CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956487512CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956487574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956489431CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956493148CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10080196943470Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2025-02-16
10080196887545Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-07-29
10193489441772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-13
10193489212624Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08