PASS LP
GUDID 03613720183983
ROD PLATE 2 LEVELS - SMALL
MEDICREA INTERNATIONAL
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 03613720183983 |
| NIH Device Record Key | 88448e75-7dc9-410f-8475-5f4cb9fadd2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PASS LP |
| Version Model Number | B02270020 |
| 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 | 03613720183983 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141398
FDA Product Code
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
Moist Heat or Steam Sterilization
[03613720183983]
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 LP]
| 03613720276043 | TRAUMA Ø6 mm PRE-BENT RODS - 50 TK |
| 03613720276036 | TRAUMA Ø6 mm PRE-BENT RODS - 26 TK |
| 03613720245742 | PEDICLE SCREWDRIVER FOR RETRIEVAL |
| 03613720245735 | CANNULATED SCREWDRIVER SHAFT |
| 03613720240846 | SPEEDRIVER WITH T-HANDLE |
| 03613720224839 | FLEXIBLE NUTDRIVER FOR CLAW |
| 03613720224761 | HOOK HOLDER |
| 03613720224754 | HOOK INSERTER SET |
| 03613720224068 | ROD HOLDER |
| 03613720224006 | NUTDRIVER AND POSITIONNER FOR PLATE AND ROD |
| 03613720223993 | SCREWDRIVER T20 |
| 03613720223986 | SELFHOLDING NUTDRIVER & BREAKER |
| 03613720223979 | HEX HOLLOW SCREW AND NUT DRIVER 10mm |
| 03613720223894 | HEXAGONAL SCREWDRIVER FOR SIMPLE SCREWS 3.5mm |
| 03613720223887 | HEX HOLLOW SCREWDRIVER FOR MONOAXIAL SCREWS 6mm |
| 03613720212287 | SACRAL PLATE HOLDER |
| 03613720212270 | BAND HOOK HOLDER |
| 03613720212263 | LIGAMENT HOOK HOLDER |
| 03613720212249 | SCREWDRIVER FOR HOOK HEAD |
| 03613720212225 | COUNTER HOOK HOLDER |
| 03613720212218 | HOOK POST HOLDER |
| 03613720212126 | NUTDRIVER SHAFT FOR DISMANTLING |
| 03613720212119 | HEXAGONAL NUTDRIVER SHAFT |
| 03613720212089 | ILIAC LINK HOLDER |
| 03613720212034 | SPEED DRIVER |
| 03613720212003 | T30 SCREWDRIVER SHAFT |
| 03613720211983 | NUT HOLDER AND THREADED EXTENSION BREAKER |
| 03613720211846 | PEDICLE SCREWDRIVER SHAFT FOR SHORT POST SCREW |
| 03613720211839 | BASIC PEDICLE SCREWDRIVER |
| 03613720211822 | PEDICLE SCREWDRIVER SHAFT FOR 1/4 POWERED DRILL DEVICE |
| 03613720211471 | OPEN CONNECTOR HOLDER |
| 03613720211440 | PARS HOOK HOLDER |
| 03613720211426 | SACRAL SCREW HOLDER FOR T20 SCREWDRIVER |
| 03613720211402 | SACRAL PLATE HOLDER |
| 03613720211365 | NUTDRIVER SHAFT |
| 03613720211358 | NUTDRIVER SHAFT FOR FINAL TIGHTENING |
| 03613720211341 | NUTDRIVER SHAFT |
| 03613720211334 | NUTDRIVER |
| 03613720211327 | NUTDRIVER FOR POSITIONING HANDLE |
| 03613720211303 | NUT HOLDER |
| 03613720211105 | ROD HOLDER |
| 03613720211037 | PASS 2 SCREWDRIVER FOR REVISION |
| 03613720211020 | PEDICLE SCREWDRIVER SHAFT |
| 03613720210788 | HEX HOLLOW NUTDRIVER 8mm |
| 03613720210771 | HEX HOLLOW SCREWDRIVER FOR CROSSLINK SYSTEM 8mm |
| 03613720210757 | T20 SCREWDRIVER SHAFT |
| 03613720210740 | NUT DRIVER SHAFT FOR FINAL TIGHTENING |
| 03613720210726 | 3.5mm HEXAGONAL SCREWDRIVER SHAFT |
| 03613720210634 | PASSMED PEDICLE SCREWDRIVER FOR REVISION |
| 03613720210627 | PEDICLE SCREWDRIVER SHAFT |
Trademark Results [PASS LP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PASS LP 79060844 3718769 Live/Registered |
MEDICREA INTERNATIONAL 2008-10-10 |
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