FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10884389706343
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA1121
Catalog number
DYNDA1121
Device description
STERILE LUBE JELLY 2 OZ.
Published
2016-09-29
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
FHXJELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHXJelly, Lubricating, For Transurethral Surgical InstrumentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912132000OPERAND LUBRICATING JELLYGeneral Medical Co.1991-08-07FHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884389706343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088438970634310884389706343

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA 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 reusable 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
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
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
10197344007035APLICAREMEDLINE INDUSTRIES, INC.FHX2024-01-23
30197344007039APLICAREMEDLINE INDUSTRIES, INC.FHX2024-01-23
10197344007042APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
30197344007046APLICAREMEDLINE INDUSTRIES, INC.FHX2023-10-31
00842209101870NAR KitNORTH AMERICAN RESCUE, LLCFHX2018-09-14
00618407002802Aplicare Lubricating JellyAPLICARE, INC.FHX2017-08-17
00618407002819Aplicare Lubricating JellyAPLICARE, INC.FHX2017-08-17
00749756026512DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
00749756033756DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
00749756770378DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756026517DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756033751DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12
50749756770373DeRoyalDEROYAL INDUSTRIES, INC.FHX2016-09-12