Primary Device ID | 00810074302395 |
NIH Device Record Key | 221c4258-1ed0-4eeb-9afc-16e355bba416 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 140mm Locking Lateral Distal Fibula Plate Right |
Version Model Number | 314-11140R |
Catalog Number | 314-11140R |
Company DUNS | 089645059 |
Company Name | Osteocentric Technologies, 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 | 1-800-969-0639 |
quality@osteocentric.com | |
Phone | 1-800-969-0639 |
quality@osteocentric.com | |
Phone | 1-800-969-0639 |
quality@osteocentric.com | |
Phone | 1-800-969-0639 |
quality@osteocentric.com | |
Phone | 1-800-969-0639 |
quality@osteocentric.com |
Length | 140 Millimeter |
Length | 140 Millimeter |
Length | 140 Millimeter |
Length | 140 Millimeter |
Length | 140 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810074302395 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810074302395]
Moist Heat or Steam Sterilization
[00810074302395]
Moist Heat or Steam Sterilization
[00810074302395]
Moist Heat or Steam Sterilization
[00810074302395]
Moist Heat or Steam Sterilization
[00810074302395]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-17 |
Device Publish Date | 2024-12-09 |
00810074302364 - 120mm Locking Lateral Distal Fibula Plate Left | 2024-12-17 120mm Locking Lateral Distal Fibula Plate Left |
00810074302371 - 140mm Locking Lateral Distal Fibula Plate Left | 2024-12-17 140mm Locking Lateral Distal Fibula Plate Left |
00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right | 2024-12-17 120mm Locking Lateral Distal Fibula Plate Right |
00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right | 2024-12-17140mm Locking Lateral Distal Fibula Plate Right |
00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right | 2024-12-17 140mm Locking Lateral Distal Fibula Plate Right |
00810074305013 - 4.0 x 125mm Drill Bit Cann AO | 2024-12-16 4.0 x 125mm Drill Bit Cann AO |
00810074306119 - 2.8 x 125mm Drill Bit Cann AO | 2024-12-16 2.8 x 125mm Drill Bit Cann AO |
00810074306133 - 1.6mm Guide Wire Smooth Trocar 150mm | 2024-12-16 1.6mm Guide Wire Smooth Trocar 150mm |
00810074306140 - 1.6mm Guide Wire Smooth Trocar 230mm | 2024-12-16 1.6mm Guide Wire Smooth Trocar 230mm |