Extended Wear

Primary DI
20610075154849
Brand
Extended Wear
Company
HOLLISTER INCORPORATED
Model
9208
Catalog number
9208
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
Rx
false
OTC
true
Sterile
false
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
20610075154849PackageGS16In Commercial Distribution
10610075154842PrimaryGS10
00610075070329Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007515484920610075154849
1061007515484210610075154842
00610075070329006100750703296100750703290610075070329

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 Diameter31Millimeter
Lumen/Inner Diameter35Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
30
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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10610075097156Adapt780678062026-03-13
10610075097163Adapt781578152026-03-13
10610075099440CeraPlus19002C19002C2026-03-01
10610075099457CeraPlus19003C19003C2026-03-01
10610075099471CeraPlus19004C19004C2026-03-01
10610075099488CeraPlus19202C19202C2026-03-01
10610075099495CeraPlus19203C19203C2026-03-01
10610075099501CeraPlus19204C19204C2026-03-01
10610075099518CeraPlus89001C89001C2026-03-01
10610075099525CeraPlus89002C89002C2026-03-01
10610075099600CeraPlus89003C89003C2026-03-01
10610075099617CeraPlus89004C89004C2026-03-01
10610075099624CeraPlus89005C89005C2026-03-01
20610075091922VaPro72082720822026-01-30
20610075092585VaPro72102721022026-01-30
20610075092592VaPro72122721222026-01-30
20610075092608VaPro72142721422026-01-30
20610075092615VaPro72084720842026-01-30
20610075092622VaPro72104721042026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mmUROCARE PRODUCTS, INC.NNX2025-01-01
00762123001660Conveen Security+Coloplast A/SNNX2022-12-06
00762123001677Conveen Security+Coloplast A/SNNX2022-12-06
00762123001684Conveen Security+Coloplast A/SNNX2022-12-06
00762123017876Conveen Security+Coloplast A/SNNX2022-12-06
05708932283304Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283267Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283342Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283380Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932283410Freedom Clear AdvantageColoplast A/SNNX2022-12-06
05708932282246Freedom ClearColoplast A/SNNX2022-12-06
05708932282017Freedom ClearColoplast A/SNNX2022-12-06
05708932282215Freedom ClearColoplast A/SNNX2022-12-06
05708932282116Freedom ClearColoplast A/SNNX2022-12-06
05708932282260Freedom ClearColoplast A/SNNX2022-12-06
05708932535939Conveen OptimaColoplast A/SNNX2022-12-06
05708932851299Conveen OptimaColoplast A/SNNX2022-12-06
05708932535953Conveen OptimaColoplast A/SNNX2022-12-06
05708932535984Conveen OptimaColoplast A/SNNX2022-12-06
00762123052433Conveen OptimaColoplast A/SNNX2022-12-06
05708932285292Freedom Active CathColoplast A/SNNX2022-12-06
05708932285124Freedom Active CathColoplast A/SNNX2022-12-06
05708932283489Freedom Active CathColoplast A/SNNX2022-12-06
05708932299503Freedom Active CathColoplast A/SNNX2022-12-06
05708932285186Freedom CathColoplast A/SNNX2022-12-06
05708932285063Freedom CathColoplast A/SNNX2022-12-06