FDA.report

SteriGear

Primary DI
10851616002004
Brand
SteriGear
Company
Sterigear, LLC
Model
A4092-81
Device description
The Fig Leaf 10270
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

Related Records

Contact Domains

Product Codes

CodeName
FCNUrinary drainage collection kit, for indwelling catheter

Product Code Classifications

CodeDeviceSpecialtyClass
FCNUrinary Drainage Collection Kit, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851616002004PackageGS120In Commercial Distribution
00851616002007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085161600200410851616002004
00851616002007008516160020078516160020070851616002007

GMDN Terms

TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods

Method
Ethylene Oxide

Contacts

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
false
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
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10851616002462SteriGearUE4001-002021-05-11
10851616002561SteriGearUE4001-002021-05-11
10851616002585SteriGearUE4001-002021-05-11
10851616002011SteriGearRE4068P-012020-11-12
10851616002028SteriGearREA4001-012020-11-17
10851616002073SteriGearREA4094-012020-11-13
10851616002035SteriGearUE4001-002020-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850063139403Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139410Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139427Neil Medical Group Neil Medical GroupFCN2025-12-08
30840330701755ProCureTwin Med, LLCFCN2025-05-31
30840330701762ProCureTwin Med, LLCFCN2025-05-31
30840330701779ProCureTwin Med, LLCFCN2025-05-31
30840330701786ProCureTwin Med, LLCFCN2025-05-31
50192253027684DoverCardinal Health 200, LLCFCN2024-10-14
50192253065488DoverCardinal Health 200, LLCFCN2024-09-03
50192253065495DoverCardinal Health 200, LLCFCN2024-09-03
50192253065617DoverCardinal Health 200, LLCFCN2024-09-03
50192253065624DoverCardinal Health 200, LLCFCN2024-09-03
50192253051610DoverCardinal Health 200, LLCFCN2024-08-08
00850053289088SURGYCOSurgyco LLCFCN2023-12-15
00850053289095SURGYCOSurgyco LLCFCN2023-12-15
00850053289101SURGYCOSurgyco LLCFCN2023-12-15
10350770003389NEOMED*Avanos Medical, Inc.FCN2021-08-27
10350770003396NEOMED*Avanos Medical, Inc.FCN2021-08-27
10350770003402NEOMED*Avanos Medical, Inc.FCN2021-08-27
10350770003419NEOMED*Avanos Medical, Inc.FCN2021-08-27
10350770003426NEOMED*Avanos Medical, Inc.FCN2021-08-27
10851616002462SteriGearSterigear, LLCFCN2021-05-11
10851616002561SteriGearSterigear, LLCFCN2021-05-11
10851616002585SteriGearSterigear, LLCFCN2021-05-11
50885380176706DoverCardinal Health, Inc.FCN2021-03-17
50885380176713DoverCardinal Health, Inc.FCN2021-03-17
50885380176720DoverCardinal Health, Inc.FCN2021-03-17
50885380176737DoverCardinal Health, Inc.FCN2021-03-17
10851616002028SteriGearSterigear, LLCFCN2020-11-17
10851616002035SteriGearSterigear, LLCFCN2020-11-17