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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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Titan™ - 10381780123781

The Centric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104620C
In Commercial Distribution

  • M269TRL09200104620C1 ()
  • 10381780123781 ()

  • 1.8 in dia x .787 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123767

The Centric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104617C
In Commercial Distribution

  • M269TRL09200104617C1 ()
  • 10381780123767 ()

  • 1.8 in dia x .669 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123750

The Eccentric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104614E
In Commercial Distribution

  • M269TRL09200104614E1 ()
  • 10381780123750 ()

  • 1.8 in dia x .551 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123743

The Centric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104614C
In Commercial Distribution

  • M269TRL09200104614C1 ()
  • 10381780123743 ()

  • 1.8 in dia x .551 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123736

The Eccentric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104419E
In Commercial Distribution

  • M269TRL09200104419E1 ()
  • 10381780123736 ()

  • 1.7 in dia x .748 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123729

The Centric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104419C
In Commercial Distribution

  • M269TRL09200104419C1 ()
  • 10381780123729 ()

  • 1.7 in dia x .748 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123712

The Eccentric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104416E
In Commercial Distribution

  • M269TRL09200104416E1 ()
  • 10381780123712 ()

  • 1.7 in dia x .63 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123705

The Centric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104416C
In Commercial Distribution

  • M269TRL09200104416C1 ()
  • 10381780123705 ()

  • 1.7 in dia x .63 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123699

The Eccentric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104216E
In Commercial Distribution

  • M269TRL09200104216E1 ()
  • 10381780123699 ()

  • 1.7 in dia x .63 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123682

The Centric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104216C
In Commercial Distribution

  • M269TRL09200104216C1 ()
  • 10381780123682 ()

  • 1.7 in dia x .63 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123675

The Eccentric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200104015E
In Commercial Distribution

  • M269TRL09200104015E1 ()
  • 10381780123675 ()

  • 1.6 in dia x .591 in H


  • Humeral head prosthesis trial, reusable

Titan™ - 10381780123668

The Eccentric Humeral Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T9200103814E
In Commercial Distribution

  • M269TRL09200103814E1 ()
  • 10381780123668 ()

  • 1.5 in dia x .551 in H


  • Humeral head prosthesis trial, reusable

uTASWako Chip Cassette - 10856626006080

The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61601
Not in Commercial Distribution

  • 10856626006080 ()
  • 00856626006083 ()
993-61601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay

DENTAL ATTACHMENTS - D821049PCM0

To provide retention with the anchorage provided by the corresponding metal attachment fixed in the mouth.
RHEIN 83 SRL
GREEN CAP MICRO SIZE pz.6
Not in Commercial Distribution

  • D821049PCM0 ()
049PCM

  • Dental implant suprastructure, permanent, preformed

ACTEON - 03609820875422

Tip, particulary slim, allows access to the light spaces between the root and the alveolar bone
SATELEC
TIP LC2 II
In Commercial Distribution

  • 03609820875422 ()
F87542

  • Dental ultrasonic surgical system handpiece tip

ACTEON - 03609820873428

Tip, particulary slim, allows access to the light spaces between the root and the alveolar bone
SATELEC
TIP LC2
In Commercial Distribution

  • 03609820873428 ()
F87342

  • Dental ultrasonic surgical system handpiece tip

Tips - D798EGTIPS1

To be used with the Get etchant in syringe as the dispensing tips for the Etchant.
RELIANCE ORTHODONTIC PRODUCTS INC
EGTIPS
Not in Commercial Distribution

  • D798EGTIPS1 ()
  • D798EGTIPS0 ()
EGTIPS

  • Dental material injection cannula, single-use

uTASWako Chip Cassette - 14987481164427

The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61601
In Commercial Distribution

  • 04987481164420 ()
  • 14987481164427 ()
  • 10856626006080 ()
993-61601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay

SURFIX® - 10381780043096

The drilling guide is used to guide the drills while preparing the holes for the 6.5 mm fixation screws.
NEWDEAL
219665ND
In Commercial Distribution

  • M248219665ND1 ()
  • 10381780043096 ()

  • 3.55mm diam. x 60mm length


  • Surgical drill guide, reusable

SURFIX® - 10381780043089

The drilling guide is used to guide the drills while preparing the holes for the 4.5 mm fixation screws.
NEWDEAL
219645ND
In Commercial Distribution

  • M248219645ND1 ()
  • 10381780043089 ()

  • 3.05mm diam. x 74mm length


  • Surgical drill guide, reusable

SURFIX® - 10381780043072

The drilling guide is used to guide the drills while preparing the holes for the 3.5 mm fixation screws.
NEWDEAL
219635ND
In Commercial Distribution

  • M248219635ND1 ()
  • 10381780043072 ()

  • 2.75mm diam. x 40mm length


  • Surgical drill guide, reusable

TIBIAXYS® - 10381780043010

The 3.0mm drilling guide is used to guide the drills while preparing the holes for the cortical fixation screws.
NEWDEAL
159130ND
In Commercial Distribution

  • M248159130ND1 ()
  • 10381780043010 ()

  • 3.1mm inner/6mm outer diameter X 10mm height


  • Surgical drill guide, reusable

PANTA® - 10381780053026

The compression wheel is part of the system used for the insertion of the nail and to perform compression.
NEWDEAL
519135ND
Not in Commercial Distribution

  • M248519135ND1 ()
  • 10381780053026 ()


  • Bone holding forceps

PANTA® - 10381780053019

The plastic ring is part of the system used for the insertion of the nail and to perform compression.
NEWDEAL
519133ND
Not in Commercial Distribution

  • M248519133ND1 ()
  • 10381780053019 ()


  • Bone holding forceps

PANTA® - 10381780053002

The threaded axis is part of the system used for the insertion of the nail and to perform compression.
NEWDEAL
519131ND
Not in Commercial Distribution

  • M248519131ND1 ()
  • 10381780053002 ()


  • Bone holding forceps

PANTA® - 10381780052999

The compression device is part of the system used for the insertion of the nail and to perform compression.
NEWDEAL
519130ND
In Commercial Distribution

  • M248519130ND1 ()
  • 10381780052999 ()


  • Bone holding forceps

PANTA® - 10381780052982

The toothed wheel is part of the system used for the insertion of the nail and to perform compression.
NEWDEAL
519121ND
Not in Commercial Distribution

  • M248519121ND1 ()
  • 10381780052982 ()


  • Bone holding forceps

PANTA® - 10381780052968

The support device is part of the system used for the insertion of the nail and to perform compression.
NEWDEAL
519110ND
In Commercial Distribution

  • M248519110ND1 ()
  • 10381780052968 ()


  • Bone holding forceps

BRAEBON Electrode Box SE - B14086120

The Electrode Box SE, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte.
Braebon Medical Corporation
8612
In Commercial Distribution

  • B14086120 ()
8612

  • Multiple physiological signal amplifier

neuro|mate® - Bone fixation pin Diameter 3,5mm - 03662724000154

A part of the fiducial fixation kit, the pin allows to prevent the rotation of the temporary implant insert.
RENISHAW MAYFIELD
Fiducial fixation kit
Not in Commercial Distribution

  • 03662724000154 ()
005.0335

  • Neurological stereotactic surgery system

Aventus Thrombectomy System - Clot Management System - 00860009303416

The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient as desired. The clot canister contains a coarse pre-filter to separate blood from clot and is designed to be compatible with off-the-shelf blood transfusion filters.
Inquis Medical, Inc.
IM-0002
In Commercial Distribution

  • 00860009303416 ()


  • Thrombectomy suction catheter

Midmark - 00841709111075

The Midmark IV Pole accessory attaches to either side of the chair and is designed to allow for necessary equipment like IV bags to be close to the patient without taking up valuable floor space.
MIDMARK CORPORATION
9A77001
In Commercial Distribution

  • 00841709111075 ()
9A77001

  • Freestanding/bed-attached intravenous pole

BIOER MagaBio plus Virus RNA Purification Kit II - 06973843228594

For detail information,please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC87L1S
In Commercial Distribution

  • 06973843228594 ()


  • Nucleic acid extraction/isolation kit IVD

BIOER MagaBio plus Virus RNA Purification Kit II - 06973843228570

For detail information,please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC87M1S
In Commercial Distribution

  • 06973843228570 ()


  • Nucleic acid extraction/isolation kit IVD

Dual-Force™ Sectional Matrix System Promo Ring Molar Green - 07540172016650

Device to engage the matrices and separate teeth
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
209016
In Commercial Distribution

  • 07540172016650 ()
209016

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Molar Rings Green - 07540172016575

Device to engage the matrices and separate teeth
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
209008
In Commercial Distribution

  • 07540172016575 ()
209008

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange - 07540172016568

Device to engage the matrices and separate teeth
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
209007
In Commercial Distribution

  • 07540172016568 ()
209007

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Assorted Ring Set - 07540172016551

Device to engage the matrices and separate teeth
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
209006
In Commercial Distribution

  • 07540172016551 ()
209006

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Assorted Ring Set - 00359883004330

Device to engage the matrices and separate teeth
DEN-MAT HOLDINGS, LLC
209006
In Commercial Distribution

  • 00359883004330 ()
209006

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Promo Ring Molar Green - 00359883000929

Device to engage the matrices and separate teeth
DEN-MAT HOLDINGS, LLC
209016
In Commercial Distribution

  • 00359883000929 ()
209016

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Molar Rings Green - 00359883000899

Device to engage the matrices and separate teeth
DEN-MAT HOLDINGS, LLC
209008
In Commercial Distribution

  • 00359883000899 ()
209008

  • Dental matrix band retainer

Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange - 00359883000882

Device to engage the matrices and separate teeth
DEN-MAT HOLDINGS, LLC
209007
In Commercial Distribution

  • 00359883000882 ()
209007

  • Dental matrix band retainer

Eardrum punch - 04250676728562

to roughen the tympanic membrane WL 9 cm
Spiggle & Theis Medizintechnik GmbH
15-761-00
In Commercial Distribution

  • 04250676728562 ()
15-761-00

  • Bone-coring punch, reusable

Fixone Instrument - 08800039102179

Instrument used to measure the depth of lesion.
AJU PHARM. CO., LTD.
Fixone.I.F-D/P
In Commercial Distribution

  • 08800039102179 ()


  • Surgical depth gauge, reusable

Medidenta - 00850046903373

second half connecting to the supply line (RED)
Medidenta
QD-Switch-B
In Commercial Distribution

  • 00850046903373 ()
QD-Switch-B

  • Dental surgical power tool motorized handpiece/set, electric

Salvaclip Comfort - 08436035353071

Belt to reposition the patient on wheel chair
MEDI CARE SYSTEM SLU
SCC4306
In Commercial Distribution

  • 08436035353231 ()
  • 08436035353071 ()


  • Wheelchair/chair/stander occupant restraint/support

Salvaclip Comfort - 08436035353064

Belt to reposition the patient on wheel chair
MEDI CARE SYSTEM SLU
SCC4305
In Commercial Distribution

  • 08436035353224 ()
  • 08436035353064 ()


  • Wheelchair/chair/stander occupant restraint/support

Salvaclip Comfort - 08436035353026

Vest to reposition the patient on wheel chair
MEDI CARE SYSTEM SLU
SCC4106
In Commercial Distribution

  • 08436035353286 ()
  • 08436035353026 ()


  • Wheelchair/chair/stander occupant restraint/support

Salvaclip Comfort - 08436035353019

Vest to reposition the patient on wheel chair
MEDI CARE SYSTEM SLU
SCC4105
In Commercial Distribution

  • 08436035353279 ()
  • 08436035353019 ()


  • Wheelchair/chair/stander occupant restraint/support

Salvaclip Comfort - 08436035353002

Vest to reposition the patient on wheel chair
MEDI CARE SYSTEM SLU
SCC4104
In Commercial Distribution

  • 08436035353262 ()
  • 08436035353002 ()


  • Wheelchair/chair/stander occupant restraint/support
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