FIX-2.0X4-PT

GUDID 00841336100107

SALVIN FIXATION SCREW 2.0MMX4MM LENGTH

Salvin Dental Specialties, Inc.

Craniofacial bone screw, non-bioabsorbable, sterile
Primary Device ID00841336100107
NIH Device Record Key85f64fff-2f9e-4db7-aa8d-e2764286ebbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIX-2.0X4-PT
Version Model NumberRev4
Company DUNS113344790
Company NameSalvin Dental Specialties, Inc.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841336100107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLScrew, Fixation, Intraosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841336100107]

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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


[00841336100107]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-30

Devices Manufactured by Salvin Dental Specialties, Inc.

00841336112032 - Salvin2024-06-10 Salvin OraMEM® Plus Resorbable Collagen Membrane - 15x20mm
00841336112049 - Salvin2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 20x30mm
00841336112056 - Salvin2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 30x40mm
00841336111929 - SALVINOSS-B2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns
00841336111936 - SALVINOSS-B2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
00841336111943 - SALVINOSS-B2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
00841336111950 - SALVINOSS-B2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
00841336111998 - SALVINOSS-B2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns

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