Sense Mirror 3895

GUDID 07392532176494

Urinary catheter positioning mirror

Dentsply Ih AB

Assistive urethral catheter-positioning mirror
Primary Device ID07392532176494
NIH Device Record Key1cf56f91-2cab-44ec-83d4-091ad90f55e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSense Mirror
Version Model Number3895
Catalog Number3895
Company DUNS354059073
Company NameDentsply Ih AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Dimensions

Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter
Width70 Millimeter
Length125 Millimeter

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS107392532176494 [Primary]

FDA Product Code

FTXMIRROR, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-23
Device Publish Date2019-12-13

Devices Manufactured by Dentsply Ih AB

07333387029023 - Navina™Consumable Set Cone2023-09-11 Navina Transanal Irrigation. Consumable set cone. 1 Water container, 15 Rectal catheters cone. Non Sterile device. Rx Only.
07392532208461 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR 5-pack
07392532208492 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR 5-pack
07392532208522 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack
07392532274305 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR
07392532274336 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR
07392532274367 - LoFric® Elle™2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR
07392532247255 - LoFric® Hydro-Kit™2020-12-14 Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 08FR

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