SALVINOSS-B

GUDID 00841336111943

SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns

Salvin Dental Specialties, Inc.

Dental bone matrix implant, animal-derived
Primary Device ID00841336111943
NIH Device Record Key6c9c6d30-771a-4932-a941-469cf94c4260
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALVINOSS-B
Version Model NumberSALVINOSS-B-2.0
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com
Phone714-525-0114
Emailinfo@sigmagraft.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841336111943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPMBone Grafting Material, Animal Source

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-04
Device Publish Date2024-05-27

On-Brand Devices [SALVINOSS-B]

00841336112018SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0 cc 250-1000 microns
00841336112001SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5 cc 250-1000 microns
00841336111998SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns
00841336111950SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
00841336111943SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
00841336111936SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
00841336111929SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns

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