ZERAMEX XT Rescue Instrument 28mm R98130

GUDID 07640161397279

Tools

Dentalpoint AG

Surgical torque wrench adaptor
Primary Device ID07640161397279
NIH Device Record Keyca7b2aa1-1596-48a8-a35d-0655eae1223c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERAMEX XT Rescue Instrument 28mm
Version Model NumberR98130
Catalog NumberR98130
Company DUNS483229493
Company NameDentalpoint AG
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+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com
Phone+41443883630
Emailpascal.wettstein@zeramex.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107640161397279 [Primary]

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


[07640161397279]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

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07640161395077 - ZERAMEX®XT Rescue-Shell XT SMALL2024-05-15 ZERAMEX®XT Rescue-Shell XT SMALL
07640161396401 - CERALOG PL Implant, Ø 3.8 L 92024-05-07 Dental Implant
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07640161396449 - CERALOG PL Implant, Ø 3.8 L 132024-05-07 Dental Implant
07640161396456 - CERALOG PL Implant, Ø 4.3 L 92024-05-07 Dental Implant
07640161396463 - CERALOG PL Implant,Ø 4.3 L 112024-05-07 Dental Implant

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