Primary Device ID | 00855369008156 |
NIH Device Record Key | 6e032b2e-6e27-4468-b324-0bb40120a6b3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XL Blunt Pin – 2.0 mm |
Version Model Number | 500251 |
Company DUNS | 830127168 |
Company Name | Si-Bone 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 | true |
OTC Over-The-Counter | false |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com | |
Phone | 855-884-3873 |
info@si-bone.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00855369008156 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
[00855369008156]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-09-18 |
Device Publish Date | 2022-12-08 |
00810055524457 - iFuse Granite Implant System-iFuse-Granite+ Instrument Set | 2024-05-29 Granite+ Instrument Set |
00810055524563 - 8-Gauge Bone Access Needle and Tamp | 2024-05-22 8-Gauge Bone Access Needle and Tamp |
00810055524617 - iFuse INTRA X Instrument Set | 2024-05-22 iFuse INTRA X Instrument Set |
00810055523788 - iFuse Bedrock Granite Implant System | 2024-03-25 9.5 mm x 40 mm iFuse Bedrock Granite Implant |
00810055523795 - iFuse Bedrock Granite Implant System | 2024-03-25 9.5 mm x 45 mm iFuse Bedrock Granite Implant |
00810055523801 - iFuse Bedrock Granite Implant System | 2024-03-25 9.5 mm x 50 mm iFuse Bedrock Granite Implant |
00810055523818 - iFuse Bedrock Granite Implant System | 2024-03-25 9.5 mm x 55 mm iFuse Bedrock Granite Implant |
00810055523825 - iFuse Bedrock Granite Implant System | 2024-03-25 9.5 mm x 60 mm iFuse Bedrock Granite Implant |