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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522554HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522585HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522592HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522608HalyardAVID MEDICAL, INC.LRO2026-06-04
10809160522622HalyardAVID MEDICAL, INC.LRO2026-06-04
10885632522543SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-06-04
10198956346369CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956348950CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956363922CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956386099CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956390928CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956391437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956399945CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956427693CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956434004CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956439436CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956441934CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956444119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956463035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956470071CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956471306CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956474703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477049CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956477759CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956478077CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956480841CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956482012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956486683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489318CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03
10198956489585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-03