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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No Description
Hasa Optix
HA-SET026
In Commercial Distribution

  • 05404027448411 ()
  • 05404027448404 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Gold based noble metal
ARGEN CORPORATION, THE
120317
In Commercial Distribution

  • D818120317 ()
120317

  • Dental casting noble alloy
No Description
edelweiss dentistry products gmbh
13220
In Commercial Distribution

  • 09120046321608 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13219
In Commercial Distribution

  • 09120046321592 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13218
In Commercial Distribution

  • 09120046321585 ()


  • Dental composite resin
  • Dental veneer, professional
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 26
In Commercial Distribution

  • 09010522000243 ()
  • 09010522001387 ()
100425

  • Dental implant stability resonance frequency analysis peg
The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only.
Ardo medical AG
63.00.42
In Commercial Distribution

  • 00814079020667 ()
  • 00814079020674 ()
63.00.42

  • Breast pump support kit, reusable
No Description
Berman Instruments LLC
BB267
Not in Commercial Distribution

  • 00810060722046 ()


  • Dental restoration carver, resin
The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM. Instrument clamps are provided non-sterile and are intended to be sterilized by the user. Instrument clamps are reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1017010 ()
U1 017 01

  • Surgical optical-tracking spatial marker connector
No Description
Berman Instruments LLC
EC026
Not in Commercial Distribution

  • 00810060722596 ()


  • Dental elevator, tooth/root
Kit Contains: CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK221
In Commercial Distribution

  • 20607915129877 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Utility Drape, 35 in. x 35 in./90 cm x 90 cm
O&M HALYARD, INC.
89353
In Commercial Distribution

  • 30680651893537 ()
  • 10680651893533 ()
89353

  • Patient surgical drape, single-use
Proximate skin Staplers (35 Regular) Contains 35 Stainless Steel Staples (Fixed Head)
ETHICON ENDO-SURGERY, LLC
PXR35
In Commercial Distribution

  • 30705036002660 ()
  • 10705036002666 ()
  • 20705036002663 ()
PXR35

  • Skin stapler/staple, non-bioabsorbable
Proximate skin Staplers (35 Wide) Contains 35 Stainless Steel Staples (Fixed Head)
ETHICON ENDO-SURGERY, LLC
PXW35
In Commercial Distribution

  • 30705036002677 ()
  • 10705036002673 ()
  • 20705036002670 ()
PXW35

  • Skin stapler/staple, non-bioabsorbable
Henry Schein® Eugenol - 4 oz bottle
DENTSPLY INTERNATIONAL INC.
1710504FG
Not in Commercial Distribution

  • D6871710504FG2 ()
  • D6871710504FG0 ()

  • 12 Bottles (4 oz each)
  • Total Volume: 4 Fluid Ounce
1710504FG

  • Denture reliner, soft, professional
DIST, MANDIBLE, 3DX, COMPLETE, 2.0-2.7 MM PIN, TI-6AL-4V
KLS-Martin L.P.
51-601-00-09
In Commercial Distribution

  • 00888118083029 ()

  • 35 X 35 MM, 4 HOLE


  • Implantable craniofacial bone distractor
Warming Cabinet 30"W x 35 1/2"H x 26 5/8"D w/(1) Solid Door w/(2) Adj Shelves
Blickman Industries, LLC
7922TS
In Commercial Distribution

  • 00850038811037 ()
14B7922200

  • Multi-purpose warming cabinet, stationary
Warming Cabinet 30"W x 35 1/2"H x 26 5/8"D w/(1) Glass Door w/(2) Adj Shelves
Blickman Industries, LLC
7922TG
In Commercial Distribution

  • 00850038811020 ()
14B7922243

  • Multi-purpose warming cabinet, stationary
4.5 x 35 mm screw
Inion Oy
1
In Commercial Distribution

  • 06438408006234 ()
FRF-1238

  • Bioabsorbable orthopaedic bone screw
2.0 x 35 mm pin
Inion Oy
1
In Commercial Distribution

  • 06438408006067 ()
PIN-2035

  • Orthopaedic bone pin, bioabsorbable
Screw 4.5 x 35 mm
Inion Oy
1
In Commercial Distribution

  • 06438408003318 ()
OSA-4535

  • Bioabsorbable orthopaedic bone screw
Screw 3.5 x 35 mm
Inion Oy
1
In Commercial Distribution

  • 06438408003288 ()
OSA-3535

  • Bioabsorbable orthopaedic bone screw
Screw 2.7 x 35 mm
Inion Oy
1
In Commercial Distribution

  • 06438408003233 ()
OSA-2735

  • Bioabsorbable orthopaedic bone screw
My LM-Activator 35 Low Short
LM-Dental
94435LS
In Commercial Distribution

  • 06438311231358 ()
94435LS

  • Orthodontic retainer
LM-Activator2 Low Long 35 Wide
LM-Dental
94235LLW
In Commercial Distribution

  • 06438311222905 ()


  • Orthodontic retainer
Curved Rod, 5.5 x 35
CAPTIVA SPINE, INC.
2455-2035
Not in Commercial Distribution

  • M73924552035 ()


  • Bone-screw internal spinal fixation system, non-sterile
Straight Rod, 5.5 x 35
CAPTIVA SPINE, INC.
2455-0035
Not in Commercial Distribution

  • M73924550035 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.0 x 35
CAPTIVA SPINE, INC.
2412-8035
Not in Commercial Distribution

  • M73924128035 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 7.5 x 35
CAPTIVA SPINE, INC.
2412-7535
Not in Commercial Distribution

  • M73924127535 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 6.5 x 35
CAPTIVA SPINE, INC.
2412-6535
Not in Commercial Distribution

  • M73924126535 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 5.5 x 35
CAPTIVA SPINE, INC.
2412-5535
Not in Commercial Distribution

  • M73924125535 ()


  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 4.9 x 35
CAPTIVA SPINE, INC.
2412-4935
Not in Commercial Distribution

  • M73924124935 ()


  • Bone-screw internal spinal fixation system, non-sterile
Absorbent Paper Points Size 35
ULTRADENT PRODUCTS, INC.
1556
In Commercial Distribution

  • 00883205037367 ()
1556

  • Endodontic paper point
EndoRez Points 35 .06 Taper
ULTRADENT PRODUCTS, INC.
1639
In Commercial Distribution

  • 00883205020697 ()
1639

  • Natural gutta-percha
Absorbent Paper Points Size 35
ULTRADENT PRODUCTS, INC.
1556
In Commercial Distribution

  • 00883205020680 ()
1556

  • Endodontic paper point
EndoRez Points 35 .02 Taper
ULTRADENT PRODUCTS, INC.
1633
In Commercial Distribution

  • 00883205020284 ()
1633

  • Natural gutta-percha
EndoRez Points 35 .04 Taper
ULTRADENT PRODUCTS, INC.
1636
In Commercial Distribution

  • 00883205020161 ()
1636

  • Natural gutta-percha
SPECIAL 35 X 90MM MESH
MEDTRONIC SOFAMOR DANEK, INC.
XIB0902-003
In Commercial Distribution

  • 00721902613760 ()


  • Vertebral body prosthesis
SPECIAL 35 X 30MM MESH
MEDTRONIC SOFAMOR DANEK, INC.
XIB0902-001
In Commercial Distribution

  • 00721902613739 ()


  • Vertebral body prosthesis
SPECIAL 35 X 60MM MESH
MEDTRONIC SOFAMOR DANEK, INC.
XIB0902-002
In Commercial Distribution

  • 00721902613753 ()

  • 35mm x 60mm


  • Vertebral body prosthesis
HFE #35 FORCEPS, MATTE FINISH
HU-FRIEDY MFG. CO., LLC
FX35E
In Commercial Distribution

  • 10889950012748 ()
FX35E

  • Tooth extraction forceps
DE Carver, OU 35 (13-10-16)
HU-FRIEDY MFG. CO., LLC
CPOU35
Not in Commercial Distribution

  • 10889950044237 ()
CPOU35

  • Dental restoration carver, amalgam, reusable
ClearFit OTS Chiari Small (35)
LONGEVITI NEURO SOLUTIONS LLC
171702
In Commercial Distribution

  • 00855113008289 ()


  • Cranial resinous compound
Elite Balance Air Mattress (35")
CORK MEDICAL, LLC
6406-5
In Commercial Distribution

  • 00851675007159 ()


  • Alternating-pressure bed mattress overlay system
FG CARBIDE 35 - BULK 100
LARES RESEARCH
FG CARBIDE 35
In Commercial Distribution

  • D950LC00141 ()
LC0014

  • Carbide dental bur, single-use
FG CARBIDE 35 - BULK 100
LARES RESEARCH
FG CARBIDE 35
Not in Commercial Distribution

  • D950LC00140 ()
LC0014

  • Carbide dental bur, single-use
35 mm Standard sizer ring
ST. JUDE MEDICAL, INC.
35mm Standard sizer ring
In Commercial Distribution

  • 05415067003928 ()

  • Outer Diameter: 35 Millimeter
905-35

  • Heart valve annulus sizer, reusable
21x25 Premium CuNiTi 35 °- Universal
Acme Monaco Corporation
AMC2125RCUNITI35
In Commercial Distribution

  • D972AMC2125RCUNITI352 ()
  • AMC2125RCUNITI350 ()


  • Orthodontic archwire
19x25 Premium CuNiTi 35 °- Universal
Acme Monaco Corporation
AMC1925RCUNITI35
In Commercial Distribution

  • D972AMC1925RCUNITI352 ()
  • AMC1925RCUNITI350 ()


  • Orthodontic archwire
.018 Premium CuNiTi 35 °- Universal
Acme Monaco Corporation
AMC18RCUNITI35
In Commercial Distribution

  • D972AMC18RCUNITI352 ()
  • AMC18RCUNITI350 ()


  • Orthodontic archwire
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