Uro-Strap® Fabric Universal Male External Catheter Strap 4.75"

Primary DI
00792293064004
Brand
Uro-Strap® Fabric Universal Male External Catheter Strap 4.75"
Company
UROCARE PRODUCTS, INC.
Model
6400
Catalog number
6400
Device description
STRAP, FABRIC, MALE, EXTERNAL, CATHETER, UNIVERSAL, LATEX-FREE, VELCRO FASTENERS, REUSABLE The Uro-Strap® is an economical solution to numerous changes of tapes and adhesive strips. An elasticized cotton & loop construction allows the self-gripping fastener to attach itself anywhere along the length of the strap making it fully adjustable to individual requirements which provides security and aids in a comfortable fit. Contains: 1 Fabric Catheter Strap, Use and Care Instructions
Published
2018-05-30
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
false

Related Records

Contact Domains

Product Codes

CodeName
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00792293064004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293064004007922930640047922930640040792293064004

GMDN Terms

TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile 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

TypeValueUnit
Device Size Text, specify0
Weight0.01Pound

Sterilization Methods

Method

Contacts

PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags

DUNS number
070637129
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mmUROCARE PRODUCTS, INC.NNX2025-01-01
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