SteriGear

Primary DI
10851616002073
Brand
SteriGear
Company
Sterigear, LLC
Model
REA4094-01
Device description
Fig Leaf Foley Catheter Kit 18 Fr. 10279
Published
2020-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851616002073PackageGS110In Commercial Distribution
00851616002076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085161600207310851616002073
00851616002076008516160020768516160020760851616002076

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral catheterization kit, sterileA collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. Because of the potential frequency of catheterization, the catheter will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass], and possibly coated with an antibiotic 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
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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851616002462SteriGearUE4001-002021-05-11
10851616002561SteriGearUE4001-002021-05-11
10851616002585SteriGearUE4001-002021-05-11
10851616002004SteriGearA4092-812020-11-13
10851616002011SteriGearRE4068P-012020-11-12
10851616002028SteriGearREA4001-012020-11-17
10851616002035SteriGearUE4001-002020-11-17