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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Neutec® Neurological Pattie • 1/4 X 1/4 Rayon, X-Ray Detectable
FIRST AID BANDAGE CO INC
35500010
In Commercial Distribution

  • 50634303550006 ()
  • 30634303550002 ()
  • 00634303550001 ()

  • Width: 6.4 Millimeter
  • Width: 0.25 Inch
  • Length: 6.4 Millimeter
  • Length: 0.25 Inch
35500010

  • Neurosurgical sponge
Fixture mount short Unigrip
Cochlear Bone Anchored Solutions AB
90238
Not in Commercial Distribution

  • 09321502040105 ()
90238

  • General external orthopaedic fixation system implantation kit, reusable
Button Chin ? Small
Stryker Leibinger GmbH & Co. KG
86010
In Commercial Distribution

  • 07613252088738 ()

  • Height: 25.0 Millimeter
  • Thickness: 4.0 Millimeter
  • Width: 40.0 Millimeter
86010

  • Chin prosthesis
Lateral Nasal Valve
Stryker Leibinger GmbH & Co. KG
7545
In Commercial Distribution

  • 07613252084006 ()
  • 37613252084007 ()

  • Height: 3.5 Millimeter
  • Diameter: 13.0 Millimeter
  • Thickness: 0.85 Millimeter
7545

  • Nasal cartilage support implant, non-bioabsorbable
Malar Implant Teardrop Standard
Stryker Leibinger GmbH & Co. KG
6323
In Commercial Distribution

  • 07613252170297 ()

  • Length: 30.0 Millimeter
  • Diameter: 5.6 Millimeter
6323

  • Orbital sphere implant
FLEXBLOCK? TF - Large
Stryker Leibinger GmbH & Co. KG
9523
In Commercial Distribution

  • 07613252086000 ()

  • Length: 95.0 Millimeter
  • Height: 98.0 Millimeter
  • Thickness: 18.0 Millimeter
9523

  • Polyethylene craniofacial tissue reconstructive material
Nu TempCement NE - Two Syringe Kit
NU RADIANCE INC
Two Syringe Kit
In Commercial Distribution

  • B77207850 ()
0785

  • Dental acrylic resin
Single use, premium study kit with two XXlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XXLarge
In Commercial Distribution

  • B14360201282 ()
  • B14360201261 ()
  • B14360201272 ()
602-0123

  • Electroencephalograph
Single use, premium study kit with two Xlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XLarge
In Commercial Distribution

  • B14360201252 ()
  • B14360201231 ()
  • B14360201242 ()
602-0123

  • Electroencephalograph
Single use, premium study kit with two large ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - Large
In Commercial Distribution

  • B14360201222 ()
  • B14360201201 ()
  • B14360201212 ()
602-0120

  • Electroencephalograph
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-348-09-74
In Commercial Distribution

  • 10888118104110 ()
  • 00888118104113 ()

  • 1.5 X 7 MM THD, TTL=9 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-348-07-74
In Commercial Distribution

  • 10888118104103 ()
  • 00888118104106 ()

  • 1.5 X 5 MM THD, TTL=7 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-348-05-74
In Commercial Distribution

  • 10888118104097 ()
  • 00888118104090 ()

  • 1.5 X 3 MM THD, TTL=5 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-347-09-74
In Commercial Distribution

  • 10888118104080 ()
  • 00888118104083 ()

  • 1.2 X 7 MM THD, TTL=9 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-347-07-74
In Commercial Distribution

  • 10888118104073 ()
  • 00888118104076 ()

  • 1.2 X 5 MM THD, TTL=7 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-347-05-74
In Commercial Distribution

  • 10888118104066 ()
  • 00888118104069 ()

  • 1.2 X 3 MM THD, TTL=5 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-348-09-71
In Commercial Distribution

  • 00888118104052 ()

  • 1.5 X 7 MM THD, TTL=9 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-348-07-71
In Commercial Distribution

  • 00888118104045 ()

  • 1.5 X 5 MM THD, TTL=7 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-348-05-71
In Commercial Distribution

  • 00888118104038 ()

  • 1.5 X 3 MM THD, TTL=5 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-347-09-71
In Commercial Distribution

  • 00888118104021 ()

  • 1.2 X 7 MM THD, TTL=9 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-347-07-71
In Commercial Distribution

  • 00888118104014 ()

  • 1.2 X 5 MM THD, TTL=7 MM


  • Implantable craniofacial bone distractor
SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
50-347-05-71
In Commercial Distribution

  • 00888118104007 ()

  • 1.2 X 3 MM THD, TTL=5 MM


  • Implantable craniofacial bone distractor
Strap Set for Klarity Shell System and T-Cushions: Two Straps 2"x 60", Two Straps 6"x60", Two 2" Tabs, Two 6"x 2" Tabs, Two 6" Adhesive Tabs
Klarity Medical Products, LLC
R565-605
In Commercial Distribution

  • 00817355025448 ()


  • Indexed-immobilization patient positioning system
2.5mm Hex Internal Connection Driver, 17mm
AMERICAN DENTAL IMPLANT CORPORATION
4DIDS
In Commercial Distribution

  • D8964DIDS0 ()
4DIDS

  • Surgical screwdriver, reusable
2.5mm Hex Internal Connection Driver, 28mm
AMERICAN DENTAL IMPLANT CORPORATION
4DIDL
In Commercial Distribution

  • D8964DIDL0 ()
4DIDL

  • Surgical screwdriver, reusable
DELTA Xtend LOCKING SCREWDRIVER INTERNAL ROD
DEPUY (IRELAND)
2307-92-004
In Commercial Distribution

  • 10603295116578 ()
230792004

  • Surgical screwdriver, reusable
MiNi Internal Hex 1.7/ L=20
Megagen Implant Co. Ltd
RCS17
In Commercial Distribution

  • 08806388231362 ()
RCS17

  • Surgical screwdriver, reusable
MiNi Internal Hex 1.7/ L=25
Megagen Implant Co. Ltd
RCL17
In Commercial Distribution

  • 08806388231171 ()
RCL17

  • Surgical screwdriver, reusable
AnyRidge Internal Hex 1.2/ L=20
Megagen Implant Co. Ltd
MUARD20
In Commercial Distribution

  • 08806388244089 ()
MUARD20

  • Fixture/appliance dental drill bit, reusable
AnyRidge Internal Ø5/ L=9/ Sleeve
Megagen Implant Co. Ltd
TANFLRCSVS
In Commercial Distribution

  • 08806388237203 ()
TANFLRCSVS

  • Surgical screwdriver, reusable
INTERNAL COUNTER TORQUE FOR ASSEMBLED VAS
Synthes GmbH
388.264
In Commercial Distribution

  • H9813882640 ()
  • 10705034772264 ()
388264

  • Surgical screwdriver, reusable
BIO | Internal Hex Driver Variable Height
BLUE SKY BIO LLC
DTGIHVR
In Commercial Distribution

  • 00810060221495 ()


  • Surgical torque wrench adaptor
INTERNAL HEX DRIVE-LOCK RATCHET DRIVER, SHORT
INTRA-LOCK INTERNATIONAL, INC.
IHDLRS
In Commercial Distribution

  • D742IHDLRS0 ()
IHDLRS

  • Dental implant system
INTERNAL HEX DRIVE-LOCK RATCHET DRIVER, LONG
INTRA-LOCK INTERNATIONAL, INC.
IHDLRL
In Commercial Distribution

  • D742IHDLRL0 ()
IHDLRL

  • Dental implant system
Internal separator for panier 239mm Internal separator for panier 510mm
Medacta International SA
75.60.004
In Commercial Distribution

  • 07630542722028 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMSTRON AP-1222OEV BATTERY MUST BUY TWO
AADCO MEDICAL, INC.
OSP-AP12220EV
In Commercial Distribution

  • 00840348505283 ()
OSP-AP12220EV

  • Custom-made medical device mount
Drill Cover, two tapes, two rubber bands, 15x198cm 6"x79"
EXACT MEDICAL MANUFACTURING, INC.
E6547
Not in Commercial Distribution

  • 00852205007083 ()
  • 00852205007076 ()


  • Medical equipment/instrument drape, single-use
Drill Cover, two tapes, two rubber bands, 15x152cm 6"x59"
EXACT MEDICAL MANUFACTURING, INC.
E6546
Not in Commercial Distribution

  • 00852205007069 ()
  • 00852205007052 ()


  • Medical equipment/instrument drape, single-use
Drill Cover, two tapes, two rubber bands, 10.5x249cm 4"x98"
EXACT MEDICAL MANUFACTURING, INC.
E6544
Not in Commercial Distribution

  • 10852205007035 ()
  • 00852205007038 ()


  • Medical equipment/instrument drape, single-use
Drill Cover, two tapes, two rubber bands, 10.5x150cm 4"x59"
EXACT MEDICAL MANUFACTURING, INC.
E6543
Not in Commercial Distribution

  • 00852205007014 ()
  • 00852205007007 ()
  • 00852205007021 ()


  • Medical equipment/instrument drape, single-use
Two Purple ComfyRay Size 2 Holders + Two G-Rings and Rods
CLIKTECH LLC
001-770
In Commercial Distribution

  • 00856200001770 ()
  • 10856200001777 ()
001-770

  • Dental x-ray film holder, reusable
Drill Cover, two tapes, two rubber bands, 15x152cm 6"x59"
EXACT MEDICAL MANUFACTURING, INC.
E6546
In Commercial Distribution

  • 16975085705441 ()
  • 06975085705444 ()
  • 26975085705448 ()
E6546

  • Medical equipment/instrument drape, single-use
Adaptor Cable Bipolar, Internal 4mm Pin
BOSTON SCIENTIFIC CORPORATION
5420
In Commercial Distribution

  • 08714729982548 ()

  • Internal 4mm Pin


  • Electrical-only medical device connection cable, reusable
CSF Reservoir (Volume: 0.6 ml)
NATUS MEDICAL INCORPORATED
NT999301
In Commercial Distribution


  • 0.6ml Internal Volume
NT999301

  • Intracerebral infusion/drainage catheter, long-term
DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW CAP
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500020034 ()
  • 10815500020031 ()

  • Internal Diameter 7.4mm
06.2100B

  • Bone-screw internal spinal fixation system, sterile
The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated connector. The CSF Reservoir can be provided alone. Other configurations include a right angle ventricular catheter (7 cm or 9 cm length) and a 15 cm introducing rod, or a 15 cm straight ventricular catheter and a right angle guide. The ventricular catheter features radiopaque length markings at 2, 4, 6, 8, 10 cm from the tip.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999301
Not in Commercial Distribution

  • 10381780034582 ()
  • M2729993011 ()

  • 0.6ml Internal Volume
999301

  • Cranial port/reservoir
The Integra Ventricular Antechamber is a radiopaque component of a Cerebrospinal Fluid (CSF) shunt. The Ventricular Antechamber Kit includes a Ventricular Antechamber, a separate Straight Ventricular Catheter, featuring radiopaque Length Markings, a Right Angle Guide and a Wire Introducer. Other configurations are available: Ventricular Antechamber alone; Ventricular Antechamber with an integrated Right Angle Ventricular Catheter (Integral Ventricular Reservoir).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
999013
Not in Commercial Distribution

  • 10381780034476 ()
  • M2729990131 ()

  • 0.3ml Internal Volume
999013

  • Cranial port/reservoir
Lateral Expandable Cage Internal, Size 21x25 mm Internal 114-122, 8 Deg.
K2M, INC.
1713-212225NL8
In Commercial Distribution

  • 10888857024823 ()

  • Width: 25 Millimeter
  • Length: 21 Millimeter
  • Height 114-122 mm
  • Angle: 8 degree
1713-212225NL8

  • Vertebral body prosthesis
Lateral Expandable Cage Internal, Size 21x25 mm Internal 114-122, 4 Deg.
K2M, INC.
1713-212225NL4
In Commercial Distribution

  • 10888857024816 ()

  • Width: 25 Millimeter
  • Angle: 4 degree
  • Height 114-122 mm
  • Length: 21 Millimeter
1713-212225NL4

  • Vertebral body prosthesis
Lateral Expandable Cage Internal, Size 21x25 mm Internal 114-122, 0 Deg.
K2M, INC.
1713-212225NL0
In Commercial Distribution

  • 10888857024809 ()

  • Width: 25 Millimeter
  • Length: 21 Millimeter
  • Height 114-122 mm
1713-212225NL0

  • Vertebral body prosthesis
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