FDA.report

Medline

Primary DI
20080196408662
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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZBFinger cot

Product Code Classifications

CodeDeviceSpecialtyClass
LZBFinger CotGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20080196408662PackageGS110In Commercial Distribution
30080196408669PackageGS110000In Commercial Distribution
10080196408665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2008019640866220080196408662
3008019640866930080196408669
1008019640866510080196408665

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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