Pi-Ku-Plast HP 36 Assortment, 54000220

GUDID EBRE540002209

Pi-Ku-Plast HP 36 Assortment, red 9 Parts 1 Assortment

bredent GmbH & Co. KG

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Primary Device IDEBRE540002209
NIH Device Record Key656f2365-fa87-4d13-a6ae-6828fb0351c1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePi-Ku-Plast HP 36 Assortment,
Version Model Number54000220
Catalog Number54000220
Company DUNS341086190
Company Namebredent GmbH & Co. KG
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com
Phone+4907309872531
Emailregulatory-affairs@bredent.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBRE540002200 [Primary]
HIBCCEBRE540002209 [Package]
Contains: EBRE540002200
Package: dummy [1 Units]
Discontinued: 2023-11-23
Not in Commercial Distribution

FDA Product Code

EGDWAX, DENTAL, INTRAORAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-01
Device Publish Date2023-11-23

On-Brand Devices [Pi-Ku-Plast HP 36 Assortment,]

EBRE540002209Pi-Ku-Plast HP 36 Assortment, red 9 Parts 1 Assortment
EBRE540002199Pi-Ku-Plast HP 36 Assortment, blue 9 Parts 1 Assortment
EBRE540002189Pi-Ku-Plast HP 36 Assortment, orange 9 Parts 1 Assortment
EBRE540002179Pi-Ku-Plast HP 36 Assortment, yellow 9 Parts 1 Assortment
EBRE540002169Pi-Ku-Plast HP 36 Assortment, transparent 9 Parts 1 Assortment

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