Aplicare Lubricating Jelly 82-280

GUDID 00618407002802

Lubricating Jelly

APLICARE, INC.

General-body orifice lubricant, sterile
Primary Device ID00618407002802
NIH Device Record Keyf7521990-6788-4e20-be01-96fb761ba134
Commercial Distribution StatusIn Commercial Distribution
Brand NameAplicare Lubricating Jelly
Version Model Number82-280
Catalog Number82-280
Company DUNS058377631
Company NameAPLICARE, INC.
Device Count1
DM Exempttrue
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com
Phone+1(800)760-3236
Emailaplicarecustomerservice@clorox.com

Device Dimensions

Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram
Device Size Text, specify0
Weight3 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100618407002802 [Primary]
GS110618407002809 [Package]
Package: box [150 Units]
In Commercial Distribution
GS120618407002806 [Package]
Package: bag [30 Units]
In Commercial Distribution
GS130618407002803 [Package]
Contains: 10618407002809
Package: case [6 Units]
In Commercial Distribution
GS140618407002800 [Package]
Package: case [1000 Units]
In Commercial Distribution
GS150618407002807 [Package]
Contains: 20618407002806
Package: case [32 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FHXJELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


[00618407002802]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-17

On-Brand Devices [Aplicare Lubricating Jelly]

00618407002819Lubricating Jelly
00618407002802Lubricating Jelly

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