PASS OCT
GUDID 03613720229919
CoCr PRE BENT ROD Ø3.5mm x 120mm
MEDICREA INTERNATIONAL
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 03613720229919 |
| NIH Device Record Key | d4cf2c30-567a-4b19-83de-98a52a722dcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PASS OCT |
| Version Model Number | B17453512 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720229919 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150918
FDA Product Code
| NKG | Orthosis, Cervical Pedicle Screw Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
[03613720229919]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2015-10-23 |
On-Brand Devices [PASS OCT]
| 03613720220886 | OCCIPITAL SCREWDRIVER SHAFT |
| 03613720220879 | OCCIPITAL AWL |
| 03613720220862 | Ø3.5mm ROD HOLDER |
| 03613720220831 | NUTDRIVER |
| 03613720220824 | PEDICLE SCREWDRIVER SHAFT |
| 03613720220732 | OCCIPITAL SCREWDRIVER |
| 03613720220626 | ROD HOLDER Ø3.5mm |
| 03613720220596 | SPEED DRIVER |
| 03613720220565 | NUT DRIVER |
| 03613720220558 | NUT HOLDER |
| 03613720220497 | PEDICLE SCREWDRIVER |
| 03613720236306 | PEDICLE SCREW Ø3.5 mm x 10 mm |
| 03613720230601 | DUAL DIAMETER ROD 3.5mm x 200mm / 6mm x 300mm |
| 03613720230595 | DUAL DIAMETER ROD 3.5mm x 200mm / 6mm x 300mm |
| 03613720230588 | DUAL DIAMETER ROD 3.5mm x 200mm / 5.5mm x 300mm |
| 03613720230571 | DUAL DIAMETER ROD 3.5mm x 200mm / 5.5mm x 300mm |
| 03613720230557 | SHANK SCREW Ø4mm x 50mm, 10mm THREADS |
| 03613720230533 | SHANK SCREW Ø4mm x 48mm, 10mm THREADS |
| 03613720230519 | SHANK SCREW Ø4mm x 46mm, 10mm THREADS |
| 03613720230496 | SHANK SCREW Ø4mm x 44mm, 10mm THREADS |
| 03613720230472 | SHANK SCREW Ø4mm x 42mm, 10mm THREADS |
| 03613720230458 | SHANK SCREW Ø4mm x 40mm, 10mm THREADS |
| 03613720230434 | SHANK SCREW Ø4mm x 38mm, 10mm THREADS |
| 03613720230410 | SHANK SCREW Ø4mm x 36mm, 10mm THREADS |
| 03613720230397 | SHANK SCREW Ø4mm x 34mm, 10mm THREADS |
| 03613720230373 | SHANK SCREW Ø4mm x 32mm, 10mm THREADS |
| 03613720230359 | SHANK SCREW Ø4mm x 30mm, 10mm THREADS |
| 03613720230335 | SHANK SCREW Ø4mm x 28mm, 10mm THREADS |
| 03613720230311 | SHANK SCREW Ø4mm x 26mm, 10mm THREADS |
| 03613720230298 | SHANK SCREW Ø4mm x 24mm, 10mm THREADS |
| 03613720230274 | SHANK SCREW Ø4mm x 22mm, 10mm THREADS |
| 03613720230250 | SHANK SCREW Ø4mm x 20mm, 10mm THREADS |
| 03613720230236 | SHANK SCREW Ø3.5mm x 50mm, 10mm THREADS |
| 03613720230212 | SHANK SCREW Ø3.5mm x 48mm, 10mm THREADS |
| 03613720230199 | SHANK SCREW Ø3.5mm x 46mm, 10mm THREADS |
| 03613720230175 | SHANK SCREW Ø3.5mm x 44mm, 10mm THREADS |
| 03613720230151 | SHANK SCREW Ø3.5mm x 42mm, 10mm THREADS |
| 03613720230137 | SHANK SCREW Ø3.5mm x 40mm, 10mm THREADS |
| 03613720230113 | SHANK SCREW Ø3.5mm x 38mm, 10mm THREADS |
| 03613720230090 | SHANK SCREW Ø3.5mm x 36mm, 10mm THREADS |
| 03613720230076 | SHANK SCREW Ø3.5mm x 34mm, 10mm THREADS |
| 03613720230052 | SHANK SCREW Ø3.5mm x 32mm, 10mm THREADS |
| 03613720230038 | SHANK SCREW Ø3.5mm x 30mm, 10mm THREADS |
| 03613720230014 | SHANK SCREW Ø3.5mm x 28mm, 10mm THREADS |
| 03613720229995 | SHANK SCREW Ø3.5mm x 26mm, 10mm THREADS |
| 03613720229971 | SHANK SCREW Ø3.5mm x 24mm, 10mm THREADS |
| 03613720229957 | SHANK SCREW Ø3.5mm x 22mm, 10mm THREADS |
| 03613720229919 | CoCr PRE BENT ROD Ø3.5mm x 120mm |
| 03613720229896 | CoCr PRE BENT ROD Ø3.5mm x 110mm |
| 03613720229872 | CoCr PRE BENT ROD Ø3.5mm x 100mm |
Trademark Results [PASS OCT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PASS OCT 79105730 4239796 Live/Registered |
MEDICREA INTERNATIONAL 2011-09-26 |
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