| Primary Device ID | 03613720274056 | 
| NIH Device Record Key | f3f5cfa2-1eb5-43bf-b5d4-79df0d302670 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PASS MIS | 
| Version Model Number | A06010140 | 
| Company DUNS | 383228632 | 
| Company Name | MEDICREA INTERNATIONAL | 
| Device Count | 1 | 
| DM Exempt | true | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 03613720274056 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
[03613720274056]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2022-01-18 | 
| Device Publish Date | 2018-07-09 | 
| 03613720213536 | STRAIGHT ROD HOLDER | 
| 03613720213529 | CURVED ROD HOLDER | 
| 03613720213499 | MIS CONNECTOR HOLDER | 
| 03613720213475 | INITIAL CONNECTOR HOLDER LEFT | 
| 03613720213468 | INITIAL CONNECTOR HOLDER RIGHT | 
| 03613720190868 | PRE-BENT MIS ROD Ø 5.5mm x 40mm | 
| 03613720210290 | O-BATCH MEDICREA CASE | 
| 03613720274056 | BLUNT K-WIRE - Ø1.6 mm x 500 mm - NITINOL | 
| 03613720274049 | TROCAR K-WIRE - Ø1.6 mm x 500 mm - NITINOL | 
| 03613720213802 | PASS MIS - TRAY 4 | 
| 03613720213796 | PASS MIS - TRAY 3 | 
| 03613720213789 | PASS MIS - TRAY 2 | 
| 03613720213772 | PASS MIS - TRAY 1 | 
| 03613720213765 | PASS MIS O-BATCH CASE N°2 | 
| 03613720213758 | PASS MIS O-BATCH CASE N°1 | 
| 03613720213673 | COUNTER TORQUE | 
| 03613720213598 | CANNULATED SCREWDRIVER | 
| 03613720213581 | NUT STARTER SHAFT | 
| 03613720213574 | NUT STARTER FOR 1/4 POWERED DRILL DEVICE | 
| 03613720213567 | NUT DRIVER | 
| 03613720213437 | CANNULATED TAP Ø 7.5mm | 
| 03613720213420 | CANNULATED TAP Ø 6.5mm | 
| 03613720213413 | CANNULATED TAP Ø 5.5mm | 
| 03613720213406 | CANNULATED TAP Ø 5mm | 
| 03613720213390 | PEDICLE PROBE | 
| 03613720210412 | LID FOR INSTRUMENT TRAY | 
| 03613720210382 | 8 COMPARTMENTS CADDY | 
| 03613720210375 | 3 COMPARTMENTS CADDY | 
| 03613720210320 | O-BATCH ROD TRAY | 
| 03613720210313 | O-BATCH INSTRUMENTS TRAY | 
| 03613720189428 | SHORT STANDARD CONNECTOR FOR Ø 6mm ROD | 
| 03613720189237 | SHORT INITIAL CONNECTOR FOR Ø 5.5mm ROD | 
| 03613720227212 | CANULATED MONOAXIAL PEDICLE SCREW Ø5,5 x 50 mm | 
| 03613720227205 | CANULATED MONOAXIAL PEDICLE SCREW Ø5 x 50 mm | 
| 03613720213703 | ANTENNA FOR COMPRESSION DISTRACTION PLIERS | 
| 03613720213697 | COMPRESSION DISTRACTION PLIERS | 
| 03613720213659 | COMPRESSION / DISTRACTION INSTRUMENT | 
| 03613720213642 | ROD GAUGE | 
| 03613720213635 | PRE-BENT ROD GAUGE | 
| 03613720213628 | T HANDLE FOR NUT DRIVER | 
| 03613720213611 | STRAIGHT HANDLE FOR NUT DRIVER | 
| 03613720213604 | SPEED DRIVER MIS | 
| 03613720213543 | ROTATION EXTENSION BREAKER | 
| 03613720213512 | STRAIGHT ROD HOLDER | 
| 03613720213505 | CURVED ROD HOLDER | 
| 03613720213482 | CONNECTOR RETRIEVER | 
| 03613720213451 | CONNECTOR HOLDER | 
| 03613720213383 | DILATOR BLADE FOR ROD HOLDER | 
| 03613720213376 | DILATOR BLADE | 
| 03613720213369 | ROUND HANDLE FOR DILATOR | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PASS MIS  79105731  4239797 Live/Registered | MEDICREA INTERNATIONAL 2011-09-26 |