OsteoMed 336-6212
GUDID 00845694098403
12H Distal Fibula Plate, Right
OSTEOMED LLC
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00845694098403 |
| NIH Device Record Key | a4fbaadc-9a99-4e6e-8473-8d5688723329 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoMed |
| Version Model Number | 336-6212 |
| Catalog Number | 336-6212 |
| Company DUNS | 606417780 |
| Company Name | OSTEOMED LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
| Length | 167 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Stored at controlled room temperature away from moisture and direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845694098403 [Primary] |
FDA Product Code
| HRS | Plate, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
[00845694098403]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-14 |
On-Brand Devices [OsteoMed]
| 00845694098434 | Cannulated Non-Slip Screwdriver Body, 6.5/7.3mm |
| 00845694098427 | 14H Distal Fibula Plate, Right |
| 00845694098410 | 13H Distal Fibula Plate, Right |
| 00845694098403 | 12H Distal Fibula Plate, Right |
| 00845694098397 | 11H Distal Fibula Plate, Right |
| 00845694098380 | 10H Distal Fibula Plate, Right |
| 00845694098373 | 9H Distal Fibula Plate, Right |
| 00845694098366 | 8H Distal Fibula Plate, Right |
| 00845694098359 | 7H Distal Fibula Plate, Right |
| 00845694098342 | 6H Distal Fibula Plate, Right |
| 00845694098335 | 5H Distal Fibula Plate, Right |
| 00845694098328 | 4H Distal Fibula Plate, Right |
| 00845694098311 | 3H Distal Fibula Plate, Right |
| 00845694098304 | 2H Distal Fibula Plate, Right |
| 00845694098298 | 14H Distal Fibula Plate, Left |
| 00845694098281 | 13H Distal Fibula Plate, Left |
| 00845694098274 | 12H Distal Fibula Plate, Left |
| 00845694098267 | 11H Distal Fibula Plate, Left |
| 00845694098250 | 10H Distal Fibula Plate, Left |
| 00845694098243 | 9H Distal Fibula Plate, Left |
| 00845694098236 | 8H Distal Fibula Plate, Left |
| 00845694098229 | 7H Distal Fibula Plate, Left |
| 00845694098212 | 6H Distal Fibula Plate, Left |
| 00845694098205 | 5H Distal Fibula Plate, Left |
| 00845694098199 | 4H Distal Fibula Plate, Left |
| 00845694098182 | 3H Distal Fibula Plate, Left |
| 00845694098175 | 2H Distal Fibula Plate, Left |
| 00845694098168 | Periosteal Elevator, 3mm Round Edge |
| 00845694098151 | Periosteal Elevator, 3mm Straight Edge |
| 00845694098144 | 3.5/4.0 Medial Column Fusion Plate, Long |
| 00845694098137 | 3.5/4.0 Medial Column Fusion Plate, Medium |
| 00845694098120 | 3.5/4.0 Medial Column Fusion Plate, Short |
| 00845694098113 | 1.6mm Driver Stem w/ Post, Medium |
| 00845694098106 | 1.9mm x 4mm Safety Screw, PC |
| 00845694098090 | 1.6mm X 5mm Auto-Drive Screw, PC |
| 00845694098083 | 1.6mm X 4mm Auto-Drive Screw, PC |
| 00845694098076 | 1.6mm X 3.5mm Auto-Drive Screw, PC |
| 00845694098069 | Rigid Sterilization Container, LG |
| 00845694098052 | Sterilization Container, 2 BPS |
| 00845694098045 | Sterilization Container, 1 BPS |
| 00845694098038 | Replacement Battery, Sterile, 2-Pack |
| 00845694098021 | Replacement Battery, Sterile |
| 00845694098014 | Pinnacle Battery Power Screw Driver |
| 00845694098007 | 2.7mm x 40mm Variable Angle Locking Screw, Sterile, Qty 5 |
| 00845694097994 | 2.7mm x 40mm Variable Angle Locking Screw, Sterile, Qty 2 |
| 00845694097987 | 2.7mm x 38mm Variable Angle Locking Screw, Sterile, Qty 5 |
| 00845694097970 | 2.7mm x 38mm Variable Angle Locking Screw, Sterile, Qty 2 |
| 00845694097963 | 2.7mm x 36mm Variable Angle Locking Screw, Sterile, Qty 5 |
| 00845694097956 | 2.7mm x 36mm Variable Angle Locking Screw, Sterile, Qty 2 |
| 00845694097949 | 2.7mm x 34mm Variable Angle Locking Screw, Sterile, Qty 5 |
Trademark Results [OsteoMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOMED 97627156 not registered Live/Pending |
OsteoMed LLC 2022-10-11 |
 OSTEOMED 76379471 2766295 Live/Registered |
OSTEOMED L.P. 2002-03-06 |
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