FDA.reportPublic FDA data

Acanthus

Primary DI
00860005762613
Brand
Acanthus
Company
Acanthus Medical Creations LLC
Model
ACC019795
Catalog number
ACC019795
Device description
Acanthus Condom Catheter Size S/M
Published
2021-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005762620PackageGS130In Commercial Distribution
00860005762644PackageGS120In Commercial Distribution
00860005762668PackageGS110In Commercial Distribution
00860005762682PackageGS150In Commercial Distribution
00860005762613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005762620008600057626208600057626200860005762620
00860005762644008600057626448600057626440860005762644
00860005762668008600057626688600057626680860005762668
00860005762682008600057626828600057626820860005762682
00860005762613008600057626138600057626130860005762613

GMDN Terms#

Term, Definition table
TermDefinition
Penis wearable urinalA non-sterile, 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
Lumen/Inner Diameter21.98Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Standard room temperature conditions

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065124205
Device count
1
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
00860010482674AcanthusANBP01979920DANBP01979920D2026-05-27
00860005762606AcanthusACC019796ACC019796, ACC0197963, ACC0197969, ACC019796022021-02-15
00860010482605AcanthusTMNCHNCH2023-06-05
00860010190845AcanthusANCH01980010ANCH019800102024-12-13
00860010190852AcanthusANCH01980020ANCH019800202024-12-13
00860010190838AcanthusANCH0198005ANCH01980052023-06-05
00860010482650AcanthusANBP01979912DANBP01979912D2025-07-28
00860010482629AcanthusANBP019799DANBP019799D2025-07-06
00860010190890AcanthusANBP01979915ANBP019799152025-05-17
00860010190876AcanthusANBP01979907ANBP019799072025-04-09
00860010190821AcanthusANBP01979920ANBP019799202024-12-03
00860010190807AcanthusANBP0197995ANBP01979952023-06-05
00860010190814AcanthusANBP01979910ANBP019799102024-12-03
00860005762668AcanthusANGTH019801ANGTH0198012023-08-04
00860005762620AcanthusACC019795ACC0197952021-03-15
00860005762637AcanthusANCH019800ANCH0198002023-06-05
00860010482643AcanthusTMNBPNBP2023-06-05
00860005762651AcanthusANBP019799ANBP0197992023-06-05
00860010482681AcanthusTMNCHNCH2023-06-05
00860010482612AcanthusTMNBPNBP2023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704923714RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
14026704923721RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
14026704923738RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
24026704923711RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
24026704923728RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
24026704923735RUSCHTELEFLEX INCORPORATEDNNY2024-05-27
00860005762620AcanthusAcanthus Medical Creations LLCNNY2021-03-15
00860005762606AcanthusAcanthus Medical Creations LLCNNY2021-02-15
14026704661708RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704661715RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704661722RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704661753RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661705RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661712RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661729RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
24026704661750RUSCHTELEFLEX INCORPORATEDNNY2019-07-17
14026704660404RUSCHTELEFLEX INCORPORATEDNNY2019-01-29
14026704660411RUSCHTELEFLEX INCORPORATEDNNY2019-01-29
04026704549504RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
04026704549542RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
04026704549566RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
04026704549863RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549508RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549546RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549560RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549867RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549836RUSCHTELEFLEX INCORPORATEDNNY2018-09-15
24026704549843RUSCHTELEFLEX INCORPORATEDNNY2018-09-15