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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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artegral - D7091970566

anteriors; shade BL4; mould IS
Merz Dental GmbH
anteriors; shade BL4; mould IS
In Commercial Distribution

  • D7091970566 ()
1970566

  • Resin artificial teeth

artegral - D7091970479

anteriors; shade BL1; mould IS
Merz Dental GmbH
anteriors; shade BL1; mould IS
In Commercial Distribution

  • D7091970479 ()
1970479

  • Resin artificial teeth

artVeneer - D7091975566

anteriors; shade BL4; mould IS
Merz Dental GmbH
anteriors; shade BL4; mould IS
In Commercial Distribution

  • D7091975566 ()
1975566

  • Resin artificial teeth

artVeneer - D7091975537

anteriors; shade BL3; mould IS
Merz Dental GmbH
anteriors; shade BL3; mould IS
In Commercial Distribution

  • D7091975537 ()
1975537

  • Resin artificial teeth

artVeneer - D7091975508

anteriors; shade BL2; mould IS
Merz Dental GmbH
anteriors; shade BL2; mould IS
In Commercial Distribution

  • D7091975508 ()
1975508

  • Resin artificial teeth

artVeneer - D7091975218

anteriors; shade B3; mould IS
Merz Dental GmbH
anteriors; shade B3; mould IS
In Commercial Distribution

  • D7091975218 ()
1975218

  • Resin artificial teeth

artVeneer - D7091975189

anteriors; shade B2; mould IS
Merz Dental GmbH
anteriors; shade B2; mould IS
In Commercial Distribution

  • D7091975189 ()
1975189

  • Resin artificial teeth

artVeneer - D7091975160

anteriors; shade B1; mould IS
Merz Dental GmbH
anteriors; shade B1; mould IS
In Commercial Distribution

  • D7091975160 ()
1975160

  • Resin artificial teeth

artVeneer - D7091975131

anteriors; shade A4; mould IS
Merz Dental GmbH
anteriors; shade A4; mould IS
In Commercial Distribution

  • D7091975131 ()
1975131

  • Resin artificial teeth

artVeneer - D7091975044

anteriors; shade A2; mould IS
Merz Dental GmbH
anteriors; shade A2; mould IS
In Commercial Distribution

  • D7091975044 ()
1975044

  • Resin artificial teeth

artVeneer - D7091975015

anteriors; shade A1; mould IS
Merz Dental GmbH
anteriors; shade A1; mould IS
In Commercial Distribution

  • D7091975015 ()
1975015

  • Resin artificial teeth

artVeneer - D7091975479

anteriors; shade BL1; mould IS
Merz Dental GmbH
anteriors; shade BL1; mould IS
In Commercial Distribution

  • D7091975479 ()
1975479

  • Resin artificial teeth

artVeneer - D7091975450

anteriors; shade D4; mould IS
Merz Dental GmbH
anteriors; shade D4; mould IS
In Commercial Distribution

  • D7091975450 ()
1975450

  • Resin artificial teeth

artVeneer - D7091975421

anteriors; shade D3; mould IS
Merz Dental GmbH
anteriors; shade D3; mould IS
In Commercial Distribution

  • D7091975421 ()
1975421

  • Resin artificial teeth

artVeneer - D7091975392

anteriors; shade D2; mould IS
Merz Dental GmbH
anteriors; shade D2; mould IS
In Commercial Distribution

  • D7091975392 ()
1975392

  • Resin artificial teeth

artVeneer - D7091975363

anteriors; shade C4; mould IS
Merz Dental GmbH
anteriors; shade C4; mould IS
In Commercial Distribution

  • D7091975363 ()
1975363

  • Resin artificial teeth

artVeneer - D7091975334

anteriors; shade C3; mould IS
Merz Dental GmbH
anteriors; shade C3; mould IS
In Commercial Distribution

  • D7091975334 ()
1975334

  • Resin artificial teeth

artVeneer - D7091975305

anteriors; shade C2; mould IS
Merz Dental GmbH
anteriors; shade C2; mould IS
In Commercial Distribution

  • D7091975305 ()
1975305

  • Resin artificial teeth

artVeneer - D7091975276

anteriors; shade C1; mould IS
Merz Dental GmbH
anteriors; shade C1; mould IS
In Commercial Distribution

  • D7091975276 ()
1975276

  • Resin artificial teeth

artVeneer - D7091975247

anteriors; shade B4; mould IS
Merz Dental GmbH
anteriors; shade B4; mould IS
In Commercial Distribution

  • D7091975247 ()
1975247

  • Resin artificial teeth

artVeneer - D7091975102

anteriors; shade A3.5; mould IS
Merz Dental GmbH
anteriors; shade A3.5; mould IS
In Commercial Distribution

  • D7091975102 ()
1975102

  • Resin artificial teeth

artVeneer - D7091975073

anteriors; shade A3; mould IS
Merz Dental GmbH
anteriors; shade A3; mould IS
In Commercial Distribution

  • D7091975073 ()
1975073

  • Resin artificial teeth

Strong Manufacturers - 00853927007962

Nitrile Classic Exam Gloves, Black, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
75035
In Commercial Distribution

  • 10853927007969 ()
  • 00853927007962 ()

  • Extra Large (XL)
  • Glove thickness is 0.08 mm or 3.1 Mils
75035

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Strong Manufacturers - 00853927007535

Nitrile Exam Gloves, Blue, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
71015
In Commercial Distribution

  • 10853927007532 ()
  • 00853927007535 ()

  • Extra Large (XL)
  • Glove thickness is 0.08 mm or 3.1 Mils
71015

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Strong Manufacturers - 00850005354253

Nitrile Pro Exam Gloves, Blue, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
71045
In Commercial Distribution

  • 10850005354250 ()
  • 00850005354253 ()

  • Extra Large (XL)
  • Glove thickness is 0.10 mm or 4.0 Mils
71045

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Strong Manufacturers - 00850005354079

Nitrile Premium Exam Gloves, Black, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
75055
In Commercial Distribution

  • 10850005354076 ()
  • 00850005354079 ()

  • Extra Large (XL)
  • Glove thickness is 0.13 mm or 5.1 Mils
75055

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Strong Manufacturers - 00850005354031

Nitrile Pro Exam Gloves, Black, Powder Free, Size Extra Large (XL), Non-Sterile, 1,000 ea per case
Strong Medical Partners LLC
75045
In Commercial Distribution

  • 10850005354038 ()
  • 00850005354031 ()

  • Extra Large (XL)
  • Glove thickness is 0.11 mm or 4.3 Mils
75045

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Strong Manufacturers - 00850005354802

Black Nitrile Exam Gloves, Powder Free, Size Extra Large (XL)
Strong Medical Partners LLC
1405
In Commercial Distribution

  • 10850005354809 ()
  • 00850005354802 ()

  • Extra Large (XL)
  • Glove thickness is 0.12 mm or 5.0 Mils
1405

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

iTotal® PS iPoly® XE Insert Kit - M572RPS0202200021

N/A
Conformis, Inc.
RPS020220002
In Commercial Distribution

  • M572RPS0202200021 ()

  • 22mm thick on the medial side, lateral side is patient specific
RPS0202200

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0202100021

ITOTAL PS IPOLY XE - 21MM INSERT – LEFT or right
Conformis, Inc.
RPS020210002
In Commercial Distribution

  • M572RPS0202100021 ()

  • 21mm thick on the medial side, lateral side is patient specific
RPS-020-2100

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0202000021

N/A
Conformis, Inc.
RPS020200002
In Commercial Distribution

  • M572RPS0202000021 ()

  • 20mm thick on the medial side, lateral side is patient specific
RPS0202000

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201900021

ITOTAL PS – IPOLY XE - 19MM INSERT - LEFT or right
Conformis, Inc.
RPS020190002
In Commercial Distribution

  • M572RPS0201900021 ()

  • 19mm thick on the medial side, lateral side is patient specific
RPS0201900

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201800021

N/A
Conformis, Inc.
RPS020180002
In Commercial Distribution

  • M572RPS0201800021 ()

  • 18mm thick on the medial side, lateral side is patient specific
RPS0201800

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201700021

N/A
Conformis, Inc.
RPS020170002
In Commercial Distribution

  • M572RPS0201700021 ()

  • 17mm thick on the medial side, lateral side is patient specific
RPS0201700

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201600021

NA
Conformis, Inc.
RPS020160002
In Commercial Distribution

  • M572RPS0201600021 ()

  • 16mm thick on the medial side, lateral side is patient specific
RPS0201600

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201500021

NA
Conformis, Inc.
RPS020150002
In Commercial Distribution

  • M572RPS0201500021 ()

  • 15mm thick on the medial side, lateral side is patient specific
RPS0201500

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201400021

NA
Conformis, Inc.
RPS020140002
In Commercial Distribution

  • M572RPS0201400021 ()

  • 14mm thick on the medial side, lateral side is patient specific
RPS0201400

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201300021

NA
Conformis, Inc.
RPS020130002
In Commercial Distribution

  • M572RPS0201300021 ()

  • 13mm thick on the medial side, lateral side is patient specific
RPS0201300

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201200021

NA
Conformis, Inc.
RPS020120002
In Commercial Distribution

  • M572RPS0201200021 ()

  • 12mm thick on the medial side, lateral side is patient specific
RPS0201200

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert

iTotal® PS iPoly® XE Insert Kit - M572RPS0201100021

NA
Conformis, Inc.
RPS020110002
In Commercial Distribution

  • M572RPS0201100021 ()

  • 11mm thick on the medial side, lateral side is patient specific
RPS0201100

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
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