SteriGear

Primary DI
00851616002014
Brand
SteriGear
Company
Sterigear, LLC
Model
RE4068P-01
Device description
Fig Leaf Foley Catheter Kit 16 Fr. 10274
Published
2020-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851616002011PackageGS110In Commercial Distribution
00851616002014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085161600201110851616002011
00851616002014008516160020148516160020140851616002014

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral catheterization kitA collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)398-3259kpetersen@propellerinc.com

Regulatory Flags#

DUNS number
809509297
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851616002076SteriGearREA4094-012020-11-13
00851616002465SteriGearUE4001-002021-05-11
00851616002564SteriGearUE4001-002021-05-11
00851616002571SteriGearUE4001-002021-05-11
10851616002462SteriGearUE4001-002021-05-11
10851616002561SteriGearUE4001-002021-05-11
10851616002585SteriGearUE4001-002021-05-11
00851616002007SteriGearA4092-812020-11-13
00851616002021SteriGearREA4001-012020-11-17
10851616002004SteriGearA4092-812020-11-13
10851616002011SteriGearRE4068P-012020-11-12
10851616002028SteriGearREA4001-012020-11-17
10851616002073SteriGearREA4094-012020-11-13
00851616002038SteriGearUE4001-002020-11-17
10851616002035SteriGearUE4001-002020-11-17