LoFric® Hydro-Kit™ 4231640

GUDID 07392532111679

Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR

Dentsply Ih AB

Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use
Primary Device ID07392532111679
NIH Device Record Key61079bc5-eb61-45e5-aba6-7632377749d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoFric® Hydro-Kit™
Version Model Number42316
Catalog Number4231640
Company DUNS354059073
Company NameDentsply Ih AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com
Phone+1(877)456-3742
Emailinfo-lofric-usa@wellspect.com

Device Dimensions

Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French
Length8 Inch
Catheter Gauge16 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS107392532111662 [Package]
Contains: 07392532142697
Package: [20 Units]
In Commercial Distribution
GS107392532111679 [Package]
Contains: 07392532111662
Package: Transport Packaging [2 Units]
In Commercial Distribution
GS107392532142697 [Primary]

FDA Product Code

EZDCATHETER, STRAIGHT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-23

On-Brand Devices [LoFric® Hydro-Kit™]

07392532175060Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 18FR
07392532175039Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR
07392532175008Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR
07392532174971Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 12FR
07392532174940Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 10FR
07392532155321Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 18FR
07392532155291Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 16FR
07392532155178Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR
07392532111709Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 18FR
07392532111679Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR
07392532111631Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 14FR
07392532092480Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 12FR
07392532111587Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR
07392532111549Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR
07392532111501Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR Paediatric
07392532111464Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR Paediatric
07392532155260Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR
07392532084034Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 12FR
07392532155208Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR
07392532247804Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 18FR
07392532247774Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR
07392532247743Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 14FR
07392532247729Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 12FR
07392532247699Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 10FR
07392532247668Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 18FR
07392532247637Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 16FR
07392532247606Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 14FR
07392532247576Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 12FR
07392532247521Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 10FR
07392532247491Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 8" 08FR
07392532247453Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR Paediatric
07392532247439Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR Paediatric
07392532247408Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 18FR
07392532247361Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 16FR
07392532247347Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR
07392532247316Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 12FR
07392532247279Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR
07392532247255Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR

Trademark Results [LoFric]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOFRIC
LOFRIC
73423764 1324299 Live/Registered
Astra Meditec Aktiebolag
1983-04-29

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