FDA.report

LoFric® Primo™

Primary DI
07392532150722
Brand
LoFric® Primo™
Company
Dentsply Ih AB
Model
41512
Catalog number
4151240
Device description
Single Use Urinary Catheter LoFric Primo Coudé 16" 12FR
Published
2016-11-23
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

Related Records

Contact Domains

Product Codes

CodeName
EZDCATHETER, STRAIGHT

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532150715PackageGS130In Commercial Distribution
07392532150722PackageGS14In Commercial Distribution
07392532131615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532150715073925321507157392532150715
07392532150722073925321507227392532150722
07392532131615073925321316157392532131615

GMDN Terms

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

TypeValueUnit
Catheter Gauge12French
Length16Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)456-3742info-lofric-usa@wellspect.com

Regulatory Flags

DUNS number
354059073
Device count
1
DM exempt
false
Premarket exempt
false
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

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