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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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SONICWELD RX, STERILE - 10888118001075

SONICPIN RX, PDLLA
KLS-Martin L.P.
52-516-57-04
In Commercial Distribution

  • 10888118001075 ()
  • 00888118001078 ()

  • 1.6 X 7 MM


  • Craniofacial bone tack, bioabsorbable

SONICWELD RX, STERILE - 10888118001068

SONICPIN RX, PDLLA
KLS-Martin L.P.
52-516-56-04
In Commercial Distribution

  • 10888118001068 ()
  • 00888118001061 ()

  • 1.6 X 6 MM


  • Craniofacial bone tack, bioabsorbable

SONICWELD RX, STERILE - 10888118001051

SONICPIN RX, PDLLA
KLS-Martin L.P.
52-516-55-04
In Commercial Distribution

  • 10888118001051 ()
  • 00888118001054 ()

  • 1.6 X 5 MM


  • Craniofacial bone tack, bioabsorbable

SONICWELD RX, STERILE - 10888118001044

SONICPIN RX, PDLLA
KLS-Martin L.P.
52-516-54-04
In Commercial Distribution

  • 10888118001044 ()
  • 00888118001047 ()

  • 1.6 X 4 MM


  • Craniofacial bone tack, bioabsorbable

SONICWELD RX, STERILE - 10888118001037

SONICPIN RX, PDLLA
KLS-Martin L.P.
52-516-25-04
In Commercial Distribution

  • 10888118001037 ()
  • 00888118001030 ()

  • 1.6 X 5 MM


  • Craniofacial bone tack, bioabsorbable

SONICWELD RX, STERILE - 10888118001020

SONICPIN RX, PDLLA
KLS-Martin L.P.
52-516-24-04
In Commercial Distribution

  • 10888118001020 ()
  • 00888118001023 ()

  • 1.6 X 4 MM


  • Craniofacial bone tack, bioabsorbable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 08 - 00359883005436

Single Step Diamond Polishers
DEN-MAT HOLDINGS, LLC
415508
In Commercial Distribution

  • 00359883005436 ()
415508

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 06 - 00359883005429

Single Step Diamond Polishers
DEN-MAT HOLDINGS, LLC
415506
In Commercial Distribution

  • 00359883005429 ()
415506

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 05 - 00359883005412

Single Step Diamond Polishers
DEN-MAT HOLDINGS, LLC
415505
In Commercial Distribution

  • 00359883005412 ()
415505

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 04 - 00359883005405

Single Step Diamond Polishers
DEN-MAT HOLDINGS, LLC
415504
In Commercial Distribution

  • 00359883005405 ()
415504

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 02 - 00359883005399

Single Step Diamond Polishers
DEN-MAT HOLDINGS, LLC
415502
In Commercial Distribution

  • 00359883005399 ()
415502

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 01 - 00359883005382

Single Step Diamond Polishers
DEN-MAT HOLDINGS, LLC
415501
In Commercial Distribution

  • 00359883005382 ()
415501

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 08 - 07540172009690

Single Step Diamond Polishers
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
415508
In Commercial Distribution

  • 07540172009690 ()
415508

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 06 - 07540172009683

Single Step Diamond Polishers
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
415506
In Commercial Distribution

  • 07540172009683 ()
415506

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 05 - 07540172009676

Single Step Diamond Polishers
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
415505
In Commercial Distribution

  • 07540172009676 ()
415505

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 04 - 07540172009669

Single Step Diamond Polishers
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
415504
In Commercial Distribution

  • 07540172009669 ()
415504

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 02 - 07540172009652

Single Step Diamond Polishers
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
415502
In Commercial Distribution

  • 07540172009652 ()
415502

  • Dental abrasive point, reusable

D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 01 - 07540172009645

Single Step Diamond Polishers
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
415501
In Commercial Distribution

  • 07540172009645 ()
415501

  • Dental abrasive point, reusable

ROOTT - 00810149980756

Abutment, 15°, 3 mm, R.
TRATE LLC
A3A15
In Commercial Distribution

  • 00810149981418 ()
  • 00810149980756 ()

  • Height: 3 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 15°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149981203

Abutment, 15°, 1 mm, R.
TRATE LLC
A1A15
In Commercial Distribution

  • 00810149981395 ()
  • 00810149981203 ()

  • Height: 1 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 15°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149981081

Abutment, 25°, 3 mm, R.
TRATE LLC
A3A25
In Commercial Distribution

  • 00810149981456 ()
  • 00810149981081 ()

  • Height: 3 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 25°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149981029

Abutment, 25°, 2 mm, R.
TRATE LLC
A2A25
In Commercial Distribution

  • 00810149981449 ()
  • 00810149981029 ()

  • Height: 2 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 25°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149981074

Abutment, 25°, 1 mm, R.
TRATE LLC
A1A25
In Commercial Distribution

  • 00810149981432 ()
  • 00810149981074 ()

  • Height: 1 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 25°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149980374

Abutment, 15°, 4 mm, R.
TRATE LLC
A4A15
In Commercial Distribution

  • 00810149981425 ()
  • 00810149980374 ()

  • Height: 4 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 15°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149980350

Abutment, 25°, 4 mm, R.
TRATE LLC
A4A25
In Commercial Distribution

  • 00810149981463 ()
  • 00810149980350 ()

  • Height: 4 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 25°


  • Dental implant suprastructure, permanent, preformed

ROOTT - 00810149980183

Abutment, 15°, 2 mm, R.
TRATE LLC
A2A15
In Commercial Distribution

  • 00810149981401 ()
  • 00810149980183 ()

  • Height: 2 Millimeter
  • Connection: cement-retained
  • Shape/form: angled 15°


  • Dental implant suprastructure, permanent, preformed

CRANIOPLATE - 04038653463978

CRANIOPLATE 1.5 BOX CAR 8HOLES
Aesculap AG
FM970T
Not in Commercial Distribution

  • 04038653463978 ()

  • Shape / Form : square
  • Height : 0.600 MM
FM970T

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

CRANIOPLATE - 04038653463961

CRANIOPLATE 1.5 BOX CAR 6HOLES
Aesculap AG
FM969T
Not in Commercial Distribution

  • 04038653463961 ()

  • Height : 0.600 MM
  • Shape / Form : square
FM969T

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

CRANIOPLATE - 04038653463954

CRANIOPLATE 1.5 BOX CAR 4HOLES
Aesculap AG
FM968T
Not in Commercial Distribution

  • 04038653463954 ()

  • Shape / Form : square
  • Height : 0.600 MM
FM968T

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

CRANIOPLATE - 04038653463947

CRANIOPLATE 1.5 Y-Y-PLATE 6HOLES L:17MM
Aesculap AG
FM967T
Not in Commercial Distribution

  • 04038653463947 ()

  • Height : 0.600 MM
  • Shape / Form : Y-Y-shaped
FM967T

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

CRANIOPLATE - 04038653463930

CRANIOPLATE 1.5 Y-Y-PLATE 6HOLES L:15MM
Aesculap AG
FM966T
Not in Commercial Distribution

  • 04038653463930 ()

  • Shape / Form : Y-Y-shaped
  • Height : 0.600 MM
FM966T

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

CRANIOPLATE - 04038653463916

CRANIOPLATE 1.5 Y-PLATE 5HOLES L:17MM
Aesculap AG
FM964T
Not in Commercial Distribution

  • 04038653463916 ()

  • Height : 0.600 MM
  • Shape / Form : Y-shaped
FM964T

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

e∙Sense - 08718122046296

e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder Single Sensor Catheter; Coudé tip shape
In Commercial Distribution

  • 08718122046296 ()
  • 38718122046297 ()

  • Length: 40 Centimeter
  • 7F Diameter
  • Coudé distal tip shape
37041105

  • Urodynamic catheter

Vac-Lok Cushion - 00841439108093

Reusable, non-sterile 108 x 125cm, 44L, T shape nylon bag for use in 1.5T and 3.0T MR environments
MEDTEC, INC.
MTVL0017
Not in Commercial Distribution

  • 00841439108093 ()

  • Length: 49.2 Inch
MTVL0017

  • Vacuum-mould patient positioning system

Integra® NuGrip® - 10381780237181

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443S
In Commercial Distribution

  • M269SHP443S1 ()
  • 10381780237181 ()

  • Size Small; .405 in dia
SHP-443-S

  • Bone cutter

Integra® NuGrip® - 10381780237174

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443M
In Commercial Distribution

  • M269SHP443M1 ()
  • 10381780237174 ()

  • Size Medium; .458 in dia
SHP-443-M

  • Bone cutter

Integra® NuGrip® - 10381780237167

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443L
In Commercial Distribution

  • M269SHP443L1 ()
  • 10381780237167 ()

  • Size Large; .520 in dia
SHP-443-L

  • Bone cutter

ONE Legend - 20726893115556

ONE Legend Urban Collection, Case of 1000 (Flared Shape)
GLOBAL PROTECTION CORP.
112100C
In Commercial Distribution

  • 80726893115558 ()
  • 20726893115556 ()


  • Basic male condom, Hevea-latex

Bingfan - 06973713959733

Lip Shape Hot / Cold Gel Pack, Red, 200pcs/CTN
Shanghai BingFan Industrial Co., Ltd.
JK-5922
In Commercial Distribution

  • 06973713959733 ()


  • Hot/cold therapy pack, reusable

Bingfan - 06973713950242

Tooth Shape Hot/Cold Gel pack, Clear, 100pcs/CTN
Shanghai BingFan Industrial Co., Ltd.
JK-5915
In Commercial Distribution

  • 06973713950242 ()


  • Hot/cold therapy pack, reusable
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