FDA.reportPublic FDA data

Cure Twist®

Primary DI
20815947020967
Brand
Cure Twist®
Company
CURE MEDICAL LLC
Model
T12K
Device description
Twist Sterile Female Catheter with Insertion Kit, Straight Tip
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
OHRCatheter Care Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2
OHRCatheter Care TrayGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080881000CURE CATHETER CLOSED SYSTEMCure Medical, LLC2008-06-11KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815947020960PackageGS130In Commercial Distribution
20815947020967PackageGS13In Commercial Distribution
00815947020963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081594702096010815947020960
2081594702096720815947020967
00815947020963008159470209638159470209630815947020963

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length15Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
070643426
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
10815947021257Cure DextraDEX142020-08-28
10815947021264Cure DextraDEX162020-08-28
10815947021271Cure DextraDEX182020-08-28
10815947020465Cure Medical Catheter Insertion KitK12016-09-24
20815947020011Cure Catheter®M102016-09-24
20815947020028Cure Catheter®M122016-09-24
20815947020035Cure Catheter®M142016-09-24
20815947020042Cure Catheter®M162016-09-24
20815947020059Cure Catheter®M182016-09-24
20815947020066Cure Catheter®M10C2016-09-24
20815947020073Cure Catheter®M12C2016-09-24
20815947020080Cure Catheter®M14C2016-09-24
20815947020097Cure Catheter®M16C2016-09-24
20815947020103Cure Catheter®M18C2016-09-24
20815947020110Cure Catheter®M12U2016-09-24
20815947020127Cure Catheter®M14U2016-09-24
20815947020134Cure Catheter®M16U2016-09-24
20815947020158Cure Pocket Coude™M12ULC2016-12-30
20815947020165Cure Pocket Coude™M14ULC2016-12-30
20815947020172Cure Pocket Coude™M16ULC2016-12-30

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Primary DI, Brand, Company table
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