FDA Registration Active 🇺🇸 United States

2.3/10 MEEK Micrograft gauze, expansion 1:3, with cork pla

Reg #: 3012366928 · FEI: 3012366928 · Expires 2025
Products
1
Proprietary Names
133
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Humeca, Inc.
Registration Number
3012366928
FEI Number
3012366928
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
9822 NE 2nd Ave Suite 7
City
Miami Shores
State
FL
ZIP
33138
Country
US

Owner / Operator

Firm Name
Humeca BV
Operator Number
10035227
Address
Oostermaat 5
City
Borne
State
NL-NOTA
Postal Code
7623 CS
Country
NL

Products

Device Name Product Code
Dermatome GFD

Proprietary Names

2.3/10 MEEK Micrograft gauze, expansion 1:3, with cork pla 3.MAC02 MEEK sterilization case 434x254x172 mm 5.BLPG10 Blades for Padgett® dermatomes, model B, C and S, 4,069 Spare part: D42 front beam, P421611 5.D42BL5PS D42 derm.blades, box 5 pcs Micrograft gauze with cork plate, 1:4, 10 pcs Humeca D42 dermatome blade, 10 pcs 4.BC6V Dermatome battery cartridge Ni-MH, 6V, 880 mAh 4,065 Spare part: power shaft, small diameter model 3.KN13/38 MEEK cutting axis with 13 ceramic coated circular Micrograft gauze with cork plate, 1:4, 40 pcs MEEK set hand drivers, complete 2.3/10  Humeca Micrograft gauze, expansion 1:3, with cork pl 5.BLPG10 Blades for Padgett® dermatomes, model B, C and S, 2.9/10 MEEK Micrograft gauze, expansion 1:9, with cork pla 4,008 Spare part: D80 blade cover 3.HD/BLO MEEK cutting machine, hand driven (block model) wit 4.D80 D80 dermatome without battery- and motor cartrid 4,033 Spare part: motor cartridge metal tube (tube only, not Humeca D80 dermatome blade, 10 pcs Width reducing clamp D80 65-22 for new model blade cover 4.BC7.4V2400 Dermatome battery cartridge Li-Ion, 7.4V, 2400 5.D80BL5PS D80 derm.blades, box 5pcs 2.3/40 MEEK Micrograft gauze, expansion 1:3, with cork pla 4.SF01 Steri4.SFle funnel for small diameter dermatome shaft 4,014 Spare part: closing cap Ni-MH 4.SB01 Sober hand dermatome, set incl. 10 blades 4.D42CL36D42 width reducing clamp 36 mm. Micrograft gauze with cork plate, 1:9, 10 pcs 4.MCX15 Dermatome motor cartridge, long (new) version 3.CB02 MEEK double cutting block with two cork holders 4.D80CL65 D80 width reducing clamp 65 mm. 2.9/10  Humeca Micrograft gauze, expansion 1:9, with cork pl 2.4/10 MEEK Micrograft gauze, expansion 1:4, with cork pl 4.SU01 Dermatome charger support unit 4,059 Spare part: Power switch support (window) with screws 3.SW01 MEEK serrated wedge (cam) 4,058 Spare part: Power switch + 2x M2x4 screws 4,064 Spare part: Viton rubber ring for motor cartridge 4.D42STS D42 dermatome, complete set, in suitcase 4.UPG1 Upgrade D42 or D80 from Ni-Mh 880mAh to Li-Ion 1200mA 4.D42 D42 dermatome without battery- and motor cartridge 4.9C94142 Dermatome battery charger Li-Ion with adaptors Micrograft gauze with cork plate, 1:3, 40 pcs 3.MAC01 MEEK sterilization case 620x260x107 mm 4,017 Spare part: closing cap Li-Ion 4.ACS410 Dermatome battery charger Ni-MH with adaptors 2.3/10 PS Mic gauze, 1:3 with cork plate 2.6/10PS Mic gauze 1:6 with cork plate 4,081 Set L-keys for Humeca dermatomes 3.CP4 MEEK pneumatic foot pedal with connectors and hose D80 Dermatome set 4.UPG4 Upgrade D80-set from Ni-Mh 880mAh or Li-Ion 1200mAh t 5.BLZM10 Blades for Zimmer® dermatomes 4.SB01 Sober hand dermatome, set incl. 10 blades 2.4/40 MEEK Micrograft gauze, expansion 1:4, with cork plate 2.4/10PS Mic gauze, 1:4 with cork plate 3.SHD MEEK hand drive set, block version (compatible with pn 5.BL4245-PS Bld.Aesculap cordless derm, box 3 4.D80CL50 D80 width reducing clamp 50 mm. 4.D42CL30 D42 width reducing clamp 30 mm. 4,066 Spare part: power shaft, large diameter model 4,071 Spare part, D42 front beam assy P421600/2 2.6/10  Humeca Micrograft gauze, expansion 1:6, with cork pl 2.6/10 MEEK Micrograft gauze, expansion 1:6, with cork pla 4.BF7.4V2400 Battery pack, Li-Ion, 7.4V, 2400 mAh (only pack 5.BL4245 Blades for Aesculap® cordless dermatomes, box 10 4.D42 AC1 D42 sterilization case 4,070 Spare part: D80 front beam, P801611 4.D80CL35 D80 width reducing clamp 35 mm. 3.MD/AUT MEEK cutting machine, automatic, without block 4.shaft40-45 Exchange dermatome Ni-MH model into 2400 Li-Ion 2.9/40 MEEK Micrograft gauze, expansion 1:9, with cork pl 4.BC7.4V1200 Dermatome battery cartridge Li-Ion, 7.4V, 1200 3.MD Humeca Micrograft gauze, expansion 1:6, with cork plate 5.BLBPG10-PS BLD. for Padgett derm model B,C &S box 3 4.ANS-HC Dermatome battery charger Li-Ion 400 mA with adapte 4,015 Spare part: D42 covering plate, stainless steel Micrograft gauze with cork plate, 1:2, 10 pcs Micrograft gauze with cork plate, 1:6, 10 pcs Humeca blade for Aesculap / Acculan dermatome, 10 pcs Width reducing clamp D42 20-20 for new model blade cover Micrograft gauze with cork plate, 1:9, 40 pcs Humeca blade for Zimmer 8801-8821 dermatome, 10 pcs Serrated wedge (cam) for double cutting block Width reducing clamp D42 36-21 for new model blade cover Humeca blade for Padgett model B, C, and S dermatomes, 10 pcs Micrograft gauze with cork plate, 1:2, 40 pcs D42 Dermatome set 3.RM004 MEEK pneumatic block motor with connectors and coupl 3.BL38MEEK circular ceramic coated blade, diameter 38 mm. 4.ANS-LC Dermatome battery charger Li-Ion, 1200 mA with adap Width reducing clamp D80 50-21 for new model blade cover 2.6/40 MEEK Micrograft gauze, expansion 1:6, with cork pl 4,072 Spare part, D80 front beam assy, P801600 5.BLSB10 Blades for Sober hand dermatome, box 10 pcs. 3.CH01 MEEK cork holder 2.JG598 STERILIT® oil for surgical instruments, bottle 50 ml 4.BF6V880 Battery pack, Ni-MH, 6V, 880 mAh (only pack, not c 3.BL38 MEEK circular ceramic coated blade, diameter 38 mm. 4.UPG3 Upgrade D80-set from Ni-Mh 880mAh or Li-Ion 1200mAh t 4.SCL Sterile clamp 4.D80AC1 D80 sterilization case 3.CA01 MEEK cutting aid 41x41 mm. 4.BF7.4V1200 Battery pack, Li-Ion, 7.4V, 1200 mAh (only pack 3.MD MEEK cutting machine, motor driven, without cutti 4,009 Spare part: D42 blade cover 5.BL4245 Blades for Aesculap® cordless dermatomes, box 10 5.BLZM10-PS BLD. for Zimmer derm. 8801 & 8821 Box 3 4.UPG2 Upgrade D42 or D80 from Ni-Mh 880 mAh to Li-Ion 1200m 2.4/10   Humeca Micrograft gauze, expansion 1:4, with cork p 3.HD/CYL MEEK cutting machine, hand driven (cylindrical mode 4.D80STS D80 dermatome, complete set, in suitcase 4,053 Spare part: dermatome lever 4.AN5207 Dermatome battery charger Li-Ion, small model 800 m 4.SF02 Sterile funnel for large diameter dermatome shaft 4,061 Spare part: microswitch 4.MC960 Dermatome motor cartridge, short (old) version MEEK set machine drivers, complete Micrograft gauze with cork plate, 1:3, 10 pcs Width reducing clamp D80 35-20 for new model blade cover Micrograft gauze with cork plate, 1:6, 40 pcs 3.CH01 MEEK cork holder 4,067 Spare part: hinge pin blade cover 5.D80BL10 D80 dermatome blades, box 10 pcs. 4,016 Spare part: D80 covering plate, stainless steel 4.BC6V Dermatome battery cartridge Ni-MH, 6V, 880 mAh 4.D42CL20 D42 width reducing clamp 20 mm 3.CB01 Meeksingle cutting block with cork holder 3.MD/GW MEEK cutting machine, motor driven, gearwheels, with 2.9/10PS Mic Gauze, 1:9, with cork plate 5.D42BL10 D42 dermatome blades, box 10 pcs. 4,062 Spare part: dermatome motor Amax 32 (only motor, no ca

Establishment Types

Complaint File Establishment per 21 CFR 820.198