FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160367713
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDL1639A
Catalog number
DYNDL1639A
Device description
STERILE DRESSING KIT
Published
2023-10-23
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
00653160367713PackageGS120In Commercial Distribution
10653160367710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160367713006531603677136531603677130653160367713
1065316036771010653160367710

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). 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
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
true
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