FDA.reportPublic FDA data

InView Extra

Primary DI
00610075205905
Brand
InView Extra
Company
HOLLISTER INCORPORATED
Model
97629-100
Catalog number
97629-100
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
20610075205909PackageGS13In Commercial Distribution
00610075205905PrimaryGS10
00610075066933Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007520590920610075205909
00610075205905006100752059056100752059050610075205905
00610075066933006100750669336100750669330610075066933

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 Diameter29Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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
10610075154651EverydayHOLLISTER 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
00610075205912InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01
00610075205929InView ExtraHOLLISTER INCORPORATEDNNX2022-12-01