FDA.reportPublic FDA data

Everyday

Primary DI
10610075154651
Brand
Everyday
Company
HOLLISTER INCORPORATED
Model
9107
Catalog number
9107
Device description
Male Incontinence Catheter, Self-Adhesive
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNXDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075154658PackageGS16In Commercial Distribution
10610075154651PrimaryGS10
30610075154655Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061007515465820610075154658
1061007515465110610075154651
3061007515465530610075154655

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-useA device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. 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
Lumen/Inner Diameter26Millimeter
Lumen/Inner Diameter30Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
30
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075096121VaPro73124731242026-08-13
00610075096138VaPro73144731442026-08-13
00610075096145VaPro73164731642026-08-13
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06
10610075029539CalciCare529937R529937R2022-12-01
10610075029546CalciCare529938R529938R2022-12-01
10610075029553CalciCare529939R529939R2022-12-01
10610075029560CalciCare529940R529940R2022-12-01
10610075029577CalciCare529967R529967R2022-11-01
10610075029584CalciCare529968R529968R2022-11-01
10610075029591CalciCare529969R529969R2022-11-01
10610075077158m9771577152022-12-01
10610075077172m9771777172022-12-01
10610075077325m9773277322022-12-01
10610075077332m9773377332022-12-01
10610075077349m9773477342022-12-01
10610075077356m9773577352022-12-01
10610075077363m9773677362022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00762123056028Conveen Security+Coloplast A/SNNX2022-12-06
00762123056042Conveen Security+Coloplast A/SNNX2022-12-06
00762123056066Conveen Security+Coloplast A/SNNX2022-12-06
00762123056080Conveen Security+Coloplast A/SNNX2022-12-06
00762123056004Conveen Security+Coloplast A/SNNX2022-12-02
00762123056011Conveen Security+Coloplast A/SNNX2022-12-02
00762123056035Conveen Security+Coloplast A/SNNX2022-12-02
00762123056059Conveen Security+Coloplast A/SNNX2022-12-02
00762123056073Conveen Security+Coloplast A/SNNX2022-12-02
10610075154644EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154668EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154675EverydayHOLLISTER INCORPORATEDNNX2022-12-01
10610075154828Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
10610075154835Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
10610075154842Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
10610075154859Extended WearHOLLISTER INCORPORATEDNNX2022-12-01
00610075205790InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205806InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205813InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205820InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205837InView SpecialHOLLISTER INCORPORATEDNNX2022-12-01
00610075205844InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205851InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205868InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205875InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205882InView StandardHOLLISTER INCORPORATEDNNX2022-12-01
00610075205899InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01
00610075205905InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01
00610075205912InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01
00610075205929InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01