allergan.com
zimmerusa.comPTG-05
Zimmer Medizinsysteme GmbH
ZIMMER MEDIZINSYSTEME GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8010720 | 7759 | ZIMMER MEDIZINSYSTEME GMBH | 1 | N | 2026-01-01 | JUNKERSSTRASSE 9 NEU-ULM Bavaria DE 89231 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04053815003304 | Soleo SonoStim - 5340 | (800) 327-3576 | info@zimmerusa.com |
| 04053815076698 | CoolTone - 5034 | (888) 935-8471 | coolsculpting.support@allergan.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 9356 | 1820920599 | K253408 | CoolTone | NGX | 2026-01-16 |
| 9356 | 1707265414 | K240347 | PTG-05 | NGX | 2024-07-21 |
| 9356 | 1885763485 | K240178 | RFG-01 | PBX | 2024-07-15 |
| 9356 | 1632205490 | K230780 | MFG-05 | KPI | 2023-10-05 |
| 9356 | 1745331256 | K230472 | Sonopuls 190 | IMI | 2023-10-24 |
| 9356 | 1641741197 | K222912 | c1Trac | ITH | 2023-05-16 |
| 9356 | 1915133480 | K220601 | CoolTone | NGX | 2022-04-01 |
| 9356 | 1544751434 | K220020 | Cryo 7 | GEX | 2022-02-04 |
| 9356 | 1476333900 | K213256 | ThermoTK | PBX | 2023-05-25 |
| 9356 | 1872604808 | K203488 | emField | IPF | 2021-02-19 |
| 9356 | 1912387989 | K192940 | CoolTone | NGX | 2019-11-15 |
| 9356 | 1679011596 | K182963 | emFieldPro | NGX | 2019-06-21 |
| 9356 | 1279183897 | K161862 | ThermoPro | IMJ | 2016-11-14 |
| 9356 | 1316943596 | K141564 | OPTON PRO | ILY | 2014-10-24 |
| 9356 | 1997422261 | K140340 | SKINTACT | GXY | 2014-05-21 |
| 9356 | 1100287858 | K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | IMG | 2012-08-07 |
| 9356 | 1194062369 | K080735 | CRYOMINI | GEX | 2008-04-04 |
| 9356 | 1878331178 | K060395 | CRYO, MODEL V6.0 | GEX | 2006-02-24 |
| 9356 | 1234798029 | ||||
| 9356 | 1686952446 | ||||
| 9356 | 1807902870 | ||||
| 9356 | 2006469619 |
Product Codes Associated With Registrations#
PMN#
RFG-01
Zimmer Medizinsysteme GmbH
MFG-05
Zimmer Medizinsysteme GmbH
ThermoTK
Zimmer Medizinsysteme GmbH
c1Trac
Zimmer Medizinsysteme GmbH
CoolTone
Zimmer MedizinSysteme GmbH
Cryo 7
Zimmer MedizinSysteme GmbH
EmField
Zimmer MedizinSysteme GmbH
CoolTone
Zimmer MedizinSysteme GmbH
EmFieldPro
Zimmer MedizinSysteme GmbH
ThermoPro
Zimmer MedizinSysteme GmbH
GUDID#
Soleo SonoStim - 5340
2016-09-24
Tecarpuls II - 1731931
2026-02-12
CoolTone - 5034
2019-12-04
Endolaser HP - 1636931
2025-03-17
EndoPuls 811 - 1650903
2025-03-17
ZStim - PTG-05
2024-07-29
ZShape - RFG-01
2024-07-19
Cryo 7 - 7375
2024-05-27
MFG-05 - 5036
2023-10-16
ThermoTK - 4802
2023-06-05
clTrac - 5143
2023-06-05
OptonPro 25W - 4687
2020-10-23
OptonPro - 4682
2016-09-24
CoolTone - 5040
2022-09-15
emField - 5038
2022-05-11
Cryo 7 - 7370
2022-03-01
Zimmertrodes - 87200171
2021-03-10
Zimmertrodes - 87200172
2021-03-10
Zimmertrodes - 87200173
2021-03-10
Zimmertrodes - 87200174
2021-03-10
Zimmertrodes - 87200171
2021-03-10
Zimmertrodes - 87200172
2021-03-10
Zimmertrodes - 87200173
2021-03-10
Zimmertrodes - 87200174
2021-03-10
Zimmertrodes - Round
2016-09-24
Zimmertrodes - Small
2016-09-24
Zimmertrodes - Large
2016-09-24
Zimmertrodes - Medium
2016-09-24
CryoOne - 5115
2020-07-05
CryoMini - 4009
2016-09-24
CryoMini - 4011
2016-09-24
Cryo-C - 5100
2016-09-24
Cryo-C - 5105
2016-09-24
Cryo 6 - 7310
2016-09-24
Cryo 6 - 7342
2016-09-24
Cryo 6 - 7343
2016-09-24
emFieldPro - 5032
2019-07-12
enPuls Version 2.0 - 5417
2020-09-23
US-Wave - 5512
2020-09-23
ZWavePro - 5531
2020-09-23