body-jet eco, 230V / 120 V/ 100 V (Model #: 500000-8)

Registration Details

Registration Name: HUMAN MED AG
Registration Number: 3003587189
FEI Number: 3003587189
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: WILHELM-HENNEMANN-STR.9
City: SCHWERIN Mecklenburg-Western Pomerania
Country: DE

Regulatory Submissions

510(k) Number: K082025

Owner / Operator

Firm Name: Human Med AG
Operator Number: 9043320
Address: WILHELM-HENNEMANN STR.9, --
City: SCHWERIN
State: DE-NOTA
Postal Code: 19061
Country: DE

US Agent

Business Name: Phil Triolo and Associates LC
Contact Name: Ryan O'Callaghan
Address: 1357 S 900 E
City: Salt Lake City
State: UT
ZIP: 84105
Country: US
Email: [email protected]
Phone: 801 5732651 ext. 0

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
System, Suction, Lipoplasty For Removal	QPB	Class 2	General, Plastic Surgery	No	2008-09-12

Proprietary Names

body-jet eco, 230V / 120 V/ 100 V (Model #: 500000-8) WAL Infiltration cannula (Model #: 500042) Biofill Infiltration cannula (Model #: 580107) WAL Irrigation and Aspiration cannula (Model #: 502003) Hydrophobic filter set (Model #: 101947) WAL Irrigation and Aspiration cannula (Model #: 501092) WAL Irrigation and Aspiration cannula (Model #: 501119) harvest-jet Applicator (for harvest-jet and harvest cannulas only) (Model #: 601001) WAL Irrigation and Aspiration cannula (Model #: 500119) harvest Infiltration cannula (Model #: 602011) WAL Irrigation and Aspiration cannula (Model #: 503001) Biofill cannula (Model #: 580089) Spacer for 15 cm cannulas, non sterile, reusable (Model #: 500054) WAL Irrigation and Aspiration cannula (Model #: 500092) harvest-jet without weighing system, 120 V (Model #: 500000-5) Biofill cannula, 3.8mm D, 15cm L, 4 suction holes (Model #: 580125) harvest Aspiration cannula (Model #: 602012) WAL Irrigation and Aspiration cannula (Model #: 500089) WAL applicator, short (Model #: 500001K) WAL Irrigation and Aspiration cannula (Model #: 502002) WAL Irrigation and Aspiration cannula (Model #: 500117) body-jet with weighing system, 120 V (Model #: 500000-1) WAL Infiltration cannula (Model #: 500028) WAL Irrigation and Aspiration cannula (Model #: 502004) WAL Irrigation and Aspiration cannula (Model #: 502001) WAL Infiltration cannula (Model #: 500121) WAL Irrigation and Aspiration cannula (Model #: 500088) WAL Irrigation and Aspiration cannula (Model #: 501089) WAL Infiltration cannula (Model #: 500107) WAL Irrigation and Aspiration cannula (Model #: 500125) WAL Irrigation and Aspiration cannula (Model #: 501125) WAL Applicator, 370 cm (for body-jet evo only) (Model #: 570001) WAL Irrigation and Aspiration cannula (Model #: 503002) WAL Irrigation and Aspiration cannula (Model #: 500086) WAL Irrigation and Aspiration cannula (Model #: 500093) WAL Infiltration cannula (Model #: 503003) WAL Infiltration cannula (Model #: 500070) WAL applicator (Model #: 500001) WAL Irrigation and Aspiration cannula (Model #: 500136) WAL Irrigation and Aspiration cannula (Model #: 500148) WAL Irrigation and Aspiration cannula, spoon-shaped tip (Model #: 500063) WAL Irrigation and Aspiration cannula (Model #: 500149) Biofill applicator, for Biofill cannulas (for body-jet evo and body-jet eco only) (Model #: 580001) WAL Irrigation/aspiration cannula, stainless steel, D 3.8mm, L 30cm, multi-hole, RAPID (Model # 503004) Biofill cannula (Model #: 580086) body-jet evo, 120 V (Model #: 500000-17) WAL Irrigation/aspiration cannula, stainless steel, D 4.8mm, L 30cm, multi-hole, RAPID (Model # 503005) WAL Irrigation and Aspiration cannula, stainless steel, 3.8mm D, 15cm L, 2x2 long suction holes, RAPID (Model #: 501151) WAL Irrigation and Aspiration cannula (Model #: 500091) WAL Irrigation and aspiration cannula, sterile, single use, 2.5 mm D, 15cm L, 180 spray jet straight (Model #: 500114S) WAL Irrigation and aspiration cannula, 3 long suction holes, 3.8mm D, 30cm L, subcutaneous, single-use (Model #: 1502004 WAL Irrigation and aspiration cannula, 4 long suction holes, 4.2mm D, 30cm L, single-use (Model #: 1500148) Biofill cannula, 3.8mm D, 15cm L, 4 suction holes, RAPID (Model #: 581125) Biofill cannula, 4 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580089) Biofill cannula, 2 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580086) Biofill cannula, 4 long suction holes, 3.8mm D, 15cm L, RAPID, single-use (Model #: 1581125) WAL Irrigation and aspiration cannula, 4 long suction holes, 3.8mm D, 30cm L, single-use (Model #: 1500125) WAL Infiltration cannula, 4.8mm D, 30cm L, single use (Model # 1500121) Biofill Infiltration cannula, 2.5mm D, 15cm L, single-use (Model #: 1580107) WAL Irrigation and aspiration cannula, 4 long suction holes, 3.8mm D, 30cm L, RAPID, single-use (Model #: 1501125) Biofill cannula, 4 long suction holes, 3.8mm D, 15cm L, single-use (Model #: 1580125) WAL Irrigation and aspiration cannula, 4.8mm D, 30cm L, multi-hole, RAPID, single-use (Model #: 1503005) WAL Infiltration cannula, 2.5mm D, 30cm L, single-use (Model #: 1500127) WAL Irrigation and aspiration cannula, 3.8mm D, 30cm L, multi-hole, RAPID, single-use (Model #: 1503004) WAL Irrigation and aspiration cannula, 4 long suction holes, 4.8mm D, 30cm L, single-use (Model #: 1500136) Hydrophobic filter set (for body-jet evo) (Model #: 103532) STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 4 suction holes, RAPID (Model #: 503002) STS Infiltration cannula, 3.5mm D, 30cm L (Model #: 503003) STS Irrigation/Aspiration cannula, 3.5mm D, 30cm L, 4 suction holes (Model #: 503089) STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 3 suction holes, SUBCUTANEOUS (Model #: 503204) STS Infiltration cannula, 2.5mm D, 25cm L (Model #: 503070) STS Irrigation/Aspiration cannula, 4.8mm D, 30cm L, 4 suction holes (Model #: 503136) STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 4 suction holes (Model #: 503001) STS Irrigation/Aspiration cannula, 4.2mm D, 30cm L, 4 suction holes (Model #: 503148)

Establishment Types

Manufacture Medical Device