FIX-1.5X17-PT

GUDID 00841336100091

SALVIN FIXATION SCREW 1.5MMX17MM LENGTH

Salvin Dental Specialties, Inc.

Craniofacial bone screw, non-bioabsorbable, sterile

Primary Device ID	00841336100091
NIH Device Record Key	9f3e025c-3eca-4c1a-ab33-dff06faf5b9f
Commercial Distribution Status	In Commercial Distribution
Brand Name	FIX-1.5X17-PT
Version Model Number	Rev3
Company DUNS	113344790
Company Name	Salvin Dental Specialties, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841336100091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K073342

FDA Product Code

DZL	Screw, Fixation, Intraosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

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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

[00841336100091]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

[00841336100091]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-30

Devices Manufactured by Salvin Dental Specialties, Inc.

00841336112032 - Salvin	2024-06-10 Salvin OraMEM® Plus Resorbable Collagen Membrane - 15x20mm
00841336112049 - Salvin	2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 20x30mm
00841336112056 - Salvin	2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 30x40mm
00841336111929 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns
00841336111936 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
00841336111943 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
00841336111950 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
00841336111998 - SALVINOSS-B	2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns

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