FDA.reportPublic FDA data

Medline

Primary DI
10080196408665
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON1569473FC
Catalog number
NON1569473FC
Device description
DBD-COT,FINGER,MEDIUM,CUSTOM
Published
2021-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZBFinger cot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZBFinger CotGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20080196408662PackageGS110In Commercial Distribution
30080196408669PackageGS110000In Commercial Distribution
10080196408665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2008019640866220080196408662
3008019640866930080196408669
1008019640866510080196408665

GMDN Terms#

Term, Definition table
TermDefinition
Finger-cot surgical drapeA protective covering made of latex designed to isolate a urological/gynaecological surgical site from contamination (e.g., microbial, substance), that has a projection (finger cot) retained within the rectum or vagina to allow repeated insertion of the surgeon's finger into the rectum (e.g., during a transurethral prostatectomy) or vagina, keeping the glove of the surgeon from being contaminated. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Contains 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
10810208581761NuCareNuCare LLCLZB2026-02-04
10810208581778NuCareNuCare LLCLZB2026-02-04
10810208581785NuCareNuCare LLCLZB2026-02-04
10810208581792NuCareNuCare LLCLZB2026-02-04
10810208581808NuCareNuCare LLCLZB2026-02-04
10884389105214MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
40884389105215MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
00057475210229BIOS LivingThermor LtdLZB2023-09-18
20057475210223BIOS LivingThermor LtdLZB2023-09-18
10665973017898Tech-MedDukal LLCLZB2022-12-09
10665973017904Tech-MedDukal LLCLZB2022-12-09
10665973017911Tech-MedDukal LLCLZB2022-12-09
10665973017928Tech-MedDukal LLCLZB2022-12-09
10665973023660Tech-MedDukal LLCLZB2022-12-06
10665973023677Tech-MedDukal LLCLZB2022-12-06
10665973023684Tech-MedDukal LLCLZB2022-12-06
10665973023691Tech-MedDukal LLCLZB2022-12-06
20665973023667Tech-MedDukal LLCLZB2022-12-06
20665973023674Tech-MedDukal LLCLZB2022-12-06
20665973023681Tech-MedDukal LLCLZB2022-12-06
20665973023698Tech-MedDukal LLCLZB2022-12-06
00814889010377Front LineProstat First Aid, LLCLZB2022-10-28
00814889013781Front LineProstat First Aid, LLCLZB2022-10-28
00814889014153Front LineProstat First Aid, LLCLZB2022-10-28
00814889014160Front LineProstat First Aid, LLCLZB2022-10-28
00814889014207Front LineProstat First Aid, LLCLZB2022-10-28
00814889010193Front LineProstat First Aid, LLCLZB2022-10-27
00814889010209Front LineProstat First Aid, LLCLZB2022-10-27
00814889013798Front LineProstat First Aid, LLCLZB2022-10-27
00073577903777First Aid OnlyAcme United CorporationLZB2022-01-22