OSSIOfiber® Trimmable Fixation Nail System OF2012430S

GUDID 07290017630267

OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm. Package contains: 2 Implants, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit.

OSSIO LTD

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID07290017630267
NIH Device Record Key3689e664-72d6-4466-af7b-c1fe67448772
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSIOfiber® Trimmable Fixation Nail System
Version Model NumberOF2012430S
Catalog NumberOF2012430S
Company DUNS600505107
Company NameOSSIO LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io

Device Dimensions

Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter
Outer Diameter2.4 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]
GS107290017630267 [Primary]

FDA Product Code

OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [OSSIOfiber® Trimmable Fixation Nail System ]

07290017630274OSSIOfiber® Trimmable Fixation Nail System, 2.4x50mm. Package contains: 1 Implant, 1 Insertion
07290017630267OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm. Package contains: 2 Implants, 1 Insertion

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