FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489782646
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA2517
Catalog number
DYNDA2517
Device description
VCUG RADIOLOGY PACK
Published
2020-05-18
Public version status
Update
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
PRRFeeding tube kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRRFeeding Tube KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489782643PackageGS120In Commercial Distribution
10193489782646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348978264320193489782643
1019348978264610193489782646

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
DM exempt
true
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
10080196144310MEDLINEDYNDX51813DYNDX518132026-06-08
10884389123997MEDLINEDYNDX50251DYNDX502512026-06-08
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956222090CARDINAL HEALTHCardinal Health 200, LLCPRR2025-11-02
10197106583913CARDINAL HEALTHCardinal Health 200, LLCPRR2024-04-16
50197106583911CARDINAL HEALTHCardinal Health 200, LLCPRR2024-04-16
10827002472843EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472850EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472867EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472874EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472881EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472898EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472904EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472911EntuitCOOK INCORPORATEDPRR2020-08-21
20193489782643MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-05-18
10193489191776MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-04-15
20193489191773MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-04-15
00653160056952CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPRR2016-09-13
50653160056957CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPRR2016-09-13