SMARTLOCK 52-27512
GUDID 34546540356032
Locking Screws, emergency, Cross-Pin
Stryker Leibinger GmbH & Co. KG
Craniofacial bone screw, non-bioabsorbable, sterile| Primary Device ID | 34546540356032 |
| NIH Device Record Key | 6c35957f-d893-450f-8259-d5358f161e8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTLOCK |
| Version Model Number | 52-27512 |
| Catalog Number | 52-27512 |
| Company DUNS | 316153956 |
| Company Name | Stryker Leibinger GmbH & Co. KG |
| Device Count | 5 |
| 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 | 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 |
Device Dimensions
| Length | 12 Millimeter |
| Length | 12 Millimeter |
| Length | 12 Millimeter |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
| Device Size Text, specify | 0 |
| Length | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540356031 [Unit of Use] |
| GS1 | 34546540356032 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K014263
FDA Product Code
| JEY | PLATE, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
[34546540356032]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-01 |
| Device Publish Date | 2015-06-16 |
On-Brand Devices [SMARTLOCK]
| 07613327462739 | LOCKING PLATE, SAGITTAL SPLIT, CURVED |
| 07613327462722 | LOCKING PLATE, SAGITTAL SPLIT, CURVED |
| 07613327462715 | LOCKING PLATE, SAGITTAL SPLIT, CURVED |
| 07613327462708 | LOCKING PLATE, SAGITTAL SPLIT, CURVED |
| 07613327460650 | PRIMARY FULL MAND PLATE,W.TEMPLATE |
| 07613327460643 | PRIMARY FULL MAND PLATE,W.TEMPLATE |
| 07613327460506 | LOCKING PLATE,SAG.SPLIT,WITH TAB |
| 07613327417876 | LOCKING PLATE,SAGIT. SPLIT,STR |
| 07613327417869 | LOCKING PLATE,SAGIT. SPLIT,STR |
| 07613327417852 | LOCKING PLATE,SAGIT. SPLIT,STR |
| 07613252450696 | LOCKING PLATE,SAGIT.SPLIT,CVD.,14MM BAR |
| 07613252267706 | LOCKING L-PLATE,W. 5MM BAR,9 HOLE,90¿ |
| 07613252237006 | LOCKING PLATE,SAGIT.SPLIT,CVD.,4MM BAR |
| 07613252236993 | LOCKING PLATE,SAGIT.SPLIT,CVD.,10MM BAR |
| 07613252236986 | LOCKING PLATE,SAGIT.SPLIT,CVD.,7MM BAR |
| 07613252236979 | LOCKING PLATE,SAGIT. SPLIT,STR,4MM BAR |
| 07613252236962 | LOCKING PLATE,SAGIT. SPLIT,STR,7MM BAR |
| 07613252236955 | LOCKING PLATE,SAGIT.SPLIT,STR,10MM BAR |
| 07613154748037 | Locking Screw, emergency, Cross-Pin |
| 07613154732456 | ANCHOR PLATE,LOCKING,T-SHAPE,SHORT,6MM |
| 07613154732289 | LOCKING PLATE, CURVED, MIDFACE |
| 07613154731954 | ANCHOR PLATE,LOCKING,STRAIGHT,SHORT,6MM |
| 07613154681686 | MAND. LOCKING PLATE,STR.,3MM BAR |
| 07613154676224 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154676217 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154676200 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154676194 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154676187 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154676170 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154676163 | LOCKING SCREW,EMERGENCY,CROSS-PIN |
| 07613154674107 | LOCKING L-PLATE, WITH BAR, MIDFACE |
| 07613154647705 | LOCKING T-PLATE,WITH BAR,MIDFACE |
| 07613154647385 | LOCKING SCREW, CROSS-PIN |
| 07613154647378 | LOCKING SCREW, CROSS-PIN |
| 07613154647361 | LOCKING SCREW, CROSS-PIN |
| 07613154647309 | LOCKING SCREW, CROSS-PIN |
| 07613154647293 | LOCKING SCREW, CROSS-PIN |
| 07613154647286 | LOCKING SCREW, CROSS-PIN |
| 07613154647279 | LOCKING SCREW, CROSS-PIN |
| 07613154647262 | LOCKING SCREW, CROSS-PIN |
| 07613154647255 | LOCKING SCREW, CROSS-PIN |
| 07613154647248 | LOCKING SCREW, CROSS-PIN |
| 07613154647231 | LOCKING SCREW, CROSS-PIN |
| 07613154647125 | LOCKING SCREW,CROSS-PIN,SELF-TAPPING |
| 07613154647118 | LOCKING SCREW,CROSS-PIN,SELF-TAPPING |
| 07613154647101 | LOCKING SCREW,CROSS-PIN,SELF-TAPPING |
| 07613154643745 | Locking Screw, Cross-Pin |
| 07613154643738 | LOCKING SCREW, CROSS-PIN |
| 07613154643721 | LOCKING SCREW, CROSS-PIN |
| 07613154643714 | LOCKING SCREW, CROSS-PIN |
Trademark Results [SMARTLOCK]
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