Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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HORIZONTAL CROSS BAR, RED 2, HALO, HOLLOW, STAINLESS STEEL
KLS-Martin L.P.
99-469-86-01
In Commercial Distribution

  • 00888118099860 ()

  • 135 MM


  • Implantable craniofacial bone distractor
DIST, RED 3, PEDIATRIC, SILVER, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118102096, 00888118102102, 00888118082534, 00888118082657, 00888118102089, 00888118082886, 00888118082350, 00888118102010, AND 00888118082671
KLS-Martin L.P.
51-585-00-04
In Commercial Distribution

  • 00888118099846 ()

  • 12 HOLE


  • Implantable craniofacial bone distractor
DIST, RED 2, ROUNDED FIXATION, PURPLE, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118082312, 00888118082329, 00888118082350, 00888118082534, 00888118102010, 00888118082657, 00888118082671, 00888118082855, AND 00888118082862
KLS-Martin L.P.
51-583-00-04
In Commercial Distribution

  • 00888118099839 ()

  • 22 HOLE


  • Implantable craniofacial bone distractor
DIST, RED 2, PURPLE, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118082312, 00888118082329, 00888118082350, 00888118082510, 00888118082527, 00888118082534, 00888118102010, 00888118082657, AND 00888118082671
KLS-Martin L.P.
51-580-00-04
In Commercial Distribution

  • 00888118099822 ()

  • 18 HOLE


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
51-579-80-04
Not in Commercial Distribution

  • 00888118099815 ()

  • 18 HOLE


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
51-579-60-04
Not in Commercial Distribution

  • 00888118099808 ()

  • 18 HOLE


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
51-579-40-04
Not in Commercial Distribution

  • 00888118099792 ()

  • 18 HOLE


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
51-579-20-04
Not in Commercial Distribution

  • 00888118099785 ()

  • 18 HOLE


  • Implantable craniofacial bone distractor
DIST, RED 2, BLACK, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118102027, 00888118102034, 00888118102041, 00888118102058, 00888118082312, 00888118082329, 00888118082350, 00888118102010, AND 00888118082671
KLS-Martin L.P.
51-579-00-04
In Commercial Distribution

  • 00888118099778 ()

  • 18 HOLE


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
99-566-51-01
Not in Commercial Distribution

  • 00888118097323 ()


  • Surgical torque wrench, reusable
SCREW, HEX, RED 2, TRIAL POSITIONING, KNURLED, FOR HALO, BLUE, TI-6AL-4V
KLS-Martin L.P.
995-3918-01
Not in Commercial Distribution

  • 00888118095244 ()

  • 51 MM


  • Implantable craniofacial bone distractor
SPLINT, RED 2, TLTS, RETENTION, T LONG, S CVD, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-472-52-01
In Commercial Distribution

  • 00888118095206 ()

  • 24 HOLE, T=1.5 MM


  • Implantable craniofacial bone distractor
PLATE, RED 2, MIDFACE FIXATION, V SHP, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
51-581-03-09
In Commercial Distribution

  • 00888118108593 ()

  • 3 HOLE


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, HALO FIXATION, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM
KLS-Martin L.P.
51-575-13-91
In Commercial Distribution

  • 00888118108463 ()

  • 2.0 X 3 MM THD, TTL=55 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, HALO FIXATION, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM
KLS-Martin L.P.
51-575-11-91
In Commercial Distribution

  • 00888118108456 ()

  • 2.0 X 3 MM THD, TTL=45 MM


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
00-906-47-04
Not in Commercial Distribution

  • 00888118099723 ()

  • 22 HOLE


  • Implantable craniofacial bone distractor
JET-X 10MM KNOB
Smith & Nephew, Inc.
E0017297-1
In Commercial Distribution

  • 00885556802762 ()
E0017297-1

  • Surgical instrument handle, non-torque-limiting
JET-X 10MM KNOB
Smith & Nephew, Inc.
E0017479-1
In Commercial Distribution

  • 00885556814642 ()
E0017479-1

  • Surgical instrument handle, non-torque-limiting
No Description
KLS-Martin L.P.
26-590-05-04
Not in Commercial Distribution

  • 00888118054159 ()


  • Implantable craniofacial bone distractor
No Description
PREMIA SPINE LTD
86037
In Commercial Distribution

  • 07290115934205 ()


  • Hand-held surgical retractor, reusable
SCREW, HEX, RED 2, MIDFACE FIXATION, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
02-581-21-09
In Commercial Distribution

  • 00888118007858 ()

  • 2.0 X 7 MM THD, TTL=27 MM


  • Implantable craniofacial bone distractor
PLATE, RED 2, MIDFACE FIXATION, T SHP, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
02-581-06-04
Not in Commercial Distribution

  • 00888118007841 ()

  • 6 HOLE


  • Implantable craniofacial bone distractor
PLATE, RED 2, MIDFACE FIXATION, STR, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
02-581-05-04
Not in Commercial Distribution

  • 00888118007834 ()

  • 5 HOLE


  • Implantable craniofacial bone distractor
UPPER PART, RED 2, MULTI DIRECTIONAL, BLACK, ALUMINUM
KLS-Martin L.P.
02-580-06-09
Not in Commercial Distribution

  • 00888118007827 ()


  • Implantable craniofacial bone distractor
VERTICAL BAR, RED 2, W/GROOVE, CARBON
KLS-Martin L.P.
02-575-17-04
Not in Commercial Distribution

  • 00888118007810 ()

  • 300 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, HALO FIXATION, KNURLED, SILVER, CP TITANIUM
KLS-Martin L.P.
02-575-12-91
In Commercial Distribution

  • 00888118007803 ()

  • TTL=55 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, HALO FIXATION, KNURLED, SILVER, CP TITANIUM
KLS-Martin L.P.
02-575-10-91
In Commercial Distribution

  • 00888118007797 ()

  • TTL=45 MM


  • Implantable craniofacial bone distractor
HORIZONTAL CROSS BAR, RED 2, TI-6AL-4V
KLS-Martin L.P.
01-001-56-07
In Commercial Distribution

  • 00888118003362 ()

  • 160 MM


  • Implantable craniofacial bone distractor
CONNECTOR, RED 2, ADJ PALATE MESH TO VERTICAL GEARED BAR, TI-6AL-4V
KLS-Martin L.P.
00-909-87-09
In Commercial Distribution

  • 00888118003218 ()


  • Implantable craniofacial bone distractor
No Description
ICECURE MEDICAL LTD
CSS-2004055
In Commercial Distribution

  • 07290015487528 ()

  • Depth: 736 Millimeter
  • Height: 1184 Millimeter
  • Width: 480 Millimeter


  • General cryosurgical system, cryogen gas, electronic
CANNULATED DRILL BIT WITH WIRE D 3.2 MM LENGTH 150 MM STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861600 ()

  • Length: 150 Millimeter
  • Outer Diameter: 3.2 Millimeter
99-11013

  • Fluted surgical drill bit, single-use
SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 150 MM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861358 ()

  • Width: 7 Millimeter
91039

  • External orthopaedic fixation system, reusable
Oxygen Sensor with External Phone Jack
MAXTEC, LLC
R125P04-001
In Commercial Distribution

  • 00853061006524 ()


  • Respiratory oxygen sensor
remede EL/EL-X external pulse generator
RESPICARDIA, INC.
1006A
In Commercial Distribution

  • 00857688007414 ()


  • Transvenous phrenic nerve electrical stimulation control unit
Defibrilator/AED Tester, External Pacer Analyzer
FLUKE ELECTRONICS CORPORATION
IMPULSE 7000DP
In Commercial Distribution

  • 00850540007126 ()
2811919

  • External defibrillator tester
Nonsterile Line Clamp, single external use
LIFEMED OF CALIFORNIA
C4531
In Commercial Distribution

  • 00852250006093 ()
  • 00852250006116 ()
C4531

  • Medical tubing clip/clamp, temporary, non-calibrated, single-use
Sidecar External Working Channel, Endoscopic Accessory
C2 THERAPEUTICS, INC.
FG-1011
In Commercial Distribution

  • 00854924006118 ()
FG-1011

  • Endoscope assembly adaptor
7 EXTERNAL EYELID WEIGHTS SIZING SET
FCI S A S FCI 20 22
S3.7000
In Commercial Distribution

  • 13700773727947 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,8 g
FCI S A S FCI 20 22
S3.60182
In Commercial Distribution

  • 13700773727916 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,8 g
FCI S A S FCI 20 22
S3.60181
In Commercial Distribution

  • 13700773727909 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,8 g
FCI S A S FCI 20 22
S3.60180
In Commercial Distribution

  • 13700773727893 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,6 g
FCI S A S FCI 20 22
S3.60162
In Commercial Distribution

  • 13700773727862 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,6 g
FCI S A S FCI 20 22
S3.60161
In Commercial Distribution

  • 13700773727855 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,6 g
FCI S A S FCI 20 22
S3.60160
In Commercial Distribution

  • 13700773727848 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,4 g
FCI S A S FCI 20 22
S3.60142
In Commercial Distribution

  • 13700773727817 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,4 g
FCI S A S FCI 20 22
S3.60141
In Commercial Distribution

  • 13700773727800 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,4 g
FCI S A S FCI 20 22
S3.60140
In Commercial Distribution

  • 13700773727794 ()


  • Eyelid weight, external
EXTERNAL OCULID TAN® - 1,2 g
FCI S A S FCI 20 22
S3.60122
In Commercial Distribution

  • 13700773727763 ()


  • Eyelid weight, external
EXTERNAL OCULID PINK® - 1,2 g
FCI S A S FCI 20 22
S3.60121
In Commercial Distribution

  • 13700773727756 ()


  • Eyelid weight, external
EXTERNAL OCULID LIGHT® - 1,2 g
FCI S A S FCI 20 22
S6.60120
In Commercial Distribution

  • 13700773727749 ()


  • Eyelid weight, external
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