FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327540952
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJRA2314
Catalog number
DYNJRA2314
Device description
PARACERVICAL/PUDENDAL BLK KIT
Published
2023-12-21
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
LROGeneral surgery tray
PVVParacervical Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
PVVParacervical Anesthesia KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327540952PackageGS120In Commercial Distribution
10195327540951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532754095240195327540952
1019532754095110195327540951

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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459760846MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-09-25
10198956172715CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956339729CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956393288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956461086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956462205CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956511286CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956520608CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956534308CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956541931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956549357CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956551541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956552791CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956554047CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956558700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561038CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956567788CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568426CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568433CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956569379CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956572522CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573734CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573857CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956574366CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956576568CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25