| Primary Device ID | 04050435067471 |
| NIH Device Record Key | a0af7974-4663-4f16-bef4-03829473ab6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONDEAL |
| Version Model Number | 27-05600 |
| Catalog Number | 27-05600 |
| Company DUNS | 312546955 |
| Company Name | MONDEAL Medical Systems GmbH |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +497463993070 |
| mail@mondeal.de | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1904-641-7746 |
| KLS-UDI-Info@klsmartin.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04050435067471 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
[04050435067471]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2017-06-26 |
| 04050435118463 | Separation sheet for inlay with empty space |
| 04050435118456 | Inlay for AKIN and CHEVRON Implants for screws Ø 1.7 / Ø 2.0 / Ø 2.3 mm, 1/4 |
| 04050435118159 | Basket L for instruments 243 x 253 x 76 mm |
| 04050435117602 | Basket complete incl. 4 silicone instrument racks and lid 273 x 84 x 41 |
| 04050435117466 | Instrument bar from silocone 160 x 34 mm |
| 04050435117190 | MRP-Plate right M3 green |
| 04050435117183 | MRP-Plate left M3 green |
| 04050435116803 | MCD blade not self-retaining M4 AO 1 x red |
| 04050435116797 | MOW plate with wedge 8 mm M2 gold |
| 04050435116780 | MOW plate with wedge 7 mm M2 gold |
| 04050435116773 | MOW plate with wedge 6 mm M2 gold |
| 04050435116766 | MOW plate with wedge 5 mm M2 gold |
| 04050435116759 | MOW plate with wedge 4 mm M2 gold |
| 04050435116742 | MOW plate with wedge 3 mm M2 gold |
| 04050435116735 | K-Wire 1.5 x 70 mm with olive Ø 6 mm Trocar pointed round shaft M2 / M3 |
| 04050435116728 | K-Wire 1.5 x 70 mm with olive Ø 4 mm Trocar pointed round shaft M1 |
| 04050435116667 | MCD Screw 2.3 x 14 mm cannulated M1 partially threaded thread length 5.6 mm violet |
| 04050435116650 | MCD Screw 2.3 x 12 mm cannulated M1 partially threaded thread length 4.8 mm violet |
| 04050435116643 | MCD Screw 2.3 x 10 mm cannulated M1 partially threaded thread length 4 mm violet |
| 04050435116636 | K-Wire 2.5 x 200 mm Trocar point threaded round shaft |
| 04050435116629 | MCD blade M4 for 200 mm K-Wire cannulated not self-retaining AO 1 x red |
| 04050435116612 | MCD blade not self-retaining M3 AO 1 x green |
| 04050435116605 | MCD blade not self-retaining M2 AO 1 x yellow |
| 04050435116599 | MCD blade not self-retaining M1 AO 1 x blue |
| 04050435116582 | K-Wire 1.4 x 150 mm Trocar point threaded round shaft |
| 04050435116575 | K-Wire 1.4 x 150 mm Trocar pointed round shaft |
| 04050435116490 | Identification label MBM blue |
| 04050435116483 | Basket S without lid 269 x 171 x 93 mm |
| 04050435116469 | Drill guide for Module 3 |
| 04050435116452 | Drill guide for Module 2 |
| 04050435116445 | Drill guide for Module 1 |
| 04050435116315 | Inlay Clip for length 45 mm |
| 04050435116308 | Inlay Clip for length 35 mm |
| 04050435116292 | Inlay Clip for length 25 mm |
| 04050435116278 | MCD Screw 6.5 x 25 mm cannulated M4 partially threaded thread length 12 mm grey |
| 04050435116261 | MCD Screw 6.5 x 30 mm cannulated M4 partially threaded thread length 15 mm grey |
| 04050435116254 | MCD Screw 6.5 x 35 mm cannulated M4 partially threaded thread length 17 mm grey |
| 04050435116247 | MCD Screw 6.5 x 40 mm cannulated M4 partially threaded thread length 20 mm grey |
| 04050435116230 | MCD Screw 6.5 x 45 mm cannulated M4 partially threaded thread length 22 mm grey |
| 04050435115950 | 4-hole X-Plate L M2 gold |
| 04050435115943 | 4-hole X-Plate M M2 gold |
| 04050435115936 | 4-hole X-Plate S M2 gold |
| 04050435115608 | Identification label BMR • MPS • FRACTURE SYSTEM blue |
| 04050435115592 | Identification label BMR • FRACTURE SYSTEM blue |
| 04050435115585 | Identification label MPS • FRACTURE SYSTEM blue |
| 04050435115578 | Identification label BMR • MPS SYSTEM blue |
| 04050435115561 | Identification label FRACTURE SYSTEM blue |
| 04050435115554 | Identification label BMR SYSTEM blue |
| 04050435115547 | Identification label MPS SYSTEM blue |
| 04050435115530 | Identification label MONDE | mandible blue |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MONDEAL 85105409 4001346 Live/Registered |
MONDEAL Medical Systems GmbH 2010-08-11 |
![]() MONDEAL 79024592 3385637 Dead/Cancelled |
Mondeal Medical Systems GmbH 2005-08-29 |
![]() MONDEAL 77931045 not registered Dead/Abandoned |
Terramis AG 2010-02-08 |
![]() MONDEAL 75093273 2092797 Dead/Cancelled |
Mondeal Medical Systems GmbH 1996-04-24 |