FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160376340
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
A2820HKIC
Catalog number
A2820HKIC
Device description
STD, VAN, 2L, 8.5F, 20CM, HKIC
Published
2024-06-25
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160376340PackageGS15In Commercial Distribution
10653160376347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160376340006531603763406531603763400653160376340
1065316037634710653160376347

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956078789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956266063CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956305861CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956349261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956354241CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956365902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956369900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956377240CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956383081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956385993CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956386266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956391598CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956414426CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956439313CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956445079CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956446694CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956453784CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956460409CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956466302CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956470415CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956470422CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956473126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956473232CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956475359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956476622CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477704CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477766CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05
10198956477889CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-05