FDA.reportPublic FDA data

Hollister

Primary DI
10610075055972
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9811
Catalog number
9811
Device description
Male Urinary Pouch, SoftFlex
Published
2022-12-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOADEVICE, PASTE-ON FOR INCONTINENCE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOADevice, Paste-On For Incontinence, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075055972PackageGS112In Commercial Distribution
00610075055975PrimaryGS10
00610075081097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007505597210610075055972
00610075055975006100750559756100750559750610075055975
00610075081097006100750810976100750810970610075081097

GMDN Terms#

Term, Definition table
TermDefinition
Penis wearable urinalAn externally-worn urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075093427Hollister934293422022-12-01
00610075093434Hollister934393432022-12-01
00610075097807Hollister978097802016-09-21
00610075097814Hollister978197812022-12-01
00610075097821Hollister978297822016-09-21
00610075097142Adapt780578052026-03-13
00610075097159Adapt780678062026-03-13
00610075097166Adapt781578152026-03-13
10610075097149Adapt780578052026-03-13
10610075097156Adapt780678062026-03-13
10610075097163Adapt781578152026-03-13
10610075198617New Image19353193532022-12-01
00610075071630Karaya 5716371632022-12-01
00610075085101Premier851085102022-12-01
00610075085132Premier851385132022-12-01
00610075085286Premier852885282022-12-01
00610075085927Premier859285922022-12-01
00610075173341Premier858485842022-12-01
00610075173365Premier85811858112022-12-01
00610075852116Premier85211852112022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653599002476Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002452Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002483Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002254Men's LibertyARGENTUM MEDICAL, LLCNOA2024-06-07
10653599002251Men's LibertyARGENTUM MEDICAL, LLCNOA2024-06-07
00653599001943Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2024-02-07
00653599002162Men's LibertyARGENTUM MEDICAL, LLCNOA2024-02-07
10653599001940Men's Liberty AcuteBIODERM, INC.NOA2024-02-07
10653599002169Men's LibertyBIODERM, INC.NOA2024-02-07
00653599002186Men's LibertyARGENTUM MEDICAL, LLCNOA2024-02-07
00653599001950Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2023-10-05
10653599001957Men's Liberty AcuteBIODERM, INC.NOA2023-10-05
10687225793749PEDIATRIC URINE COLLECTORS, CLEANPRECISION DYNAMICS CORPORATIONNOA2023-06-20
00610075055975HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00610075055982HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00610075098736HollisterHOLLISTER INCORPORATEDNOA2022-12-01
10610075055989HollisterHOLLISTER INCORPORATEDNOA2022-12-01
20610075098730HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00653599001837Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2022-06-23
10653599001834Men's Liberty AcuteBIODERM, INC.NOA2022-06-23
00653599001813Men's LibertyARGENTUM MEDICAL, LLCNOA2022-05-04
10653599001810Men's LibertyBIODERM, INC.NOA2022-05-04
00653599001790Men's LibertyARGENTUM MEDICAL, LLCNOA2021-12-20
00653599001806BioDerm (Men's Liberty Acute) 4-PackARGENTUM MEDICAL, LLCNOA2021-12-20
10653599001797Men's LibertyBIODERM, INC.NOA2021-12-20
10653599001803BioDerm (Men's Liberty Acute) 4-PackBIODERM, INC.NOA2021-12-20
00653599001639Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2021-09-20
10653599001636Men's Liberty AcuteBIODERM, INC.NOA2021-09-20
00653599001646Men's LibertyARGENTUM MEDICAL, LLCNOA2021-09-20
00653599001653Faceplate StripARGENTUM MEDICAL, LLCNOA2021-09-20