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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HI-LINE XS DISP.DIAMOND BURR I+ D2.7MM
Aesculap AG
GE465SU
Not in Commercial Distribution

  • 04046963816230 ()
GE465SU

  • Orthopaedic bur, single-use
HI-LINE XS DISP.DIAMOND BURR I D0.8MM
Aesculap AG
GE460SU
In Commercial Distribution

  • 04046963816223 ()
GE460SU

  • Orthopaedic bur, single-use
HI-LINE XS DISP.DIAMOND BURR I D0.6MM
Aesculap AG
GE459SU
In Commercial Distribution

  • 04046963816216 ()
GE459SU

  • Orthopaedic bur, single-use
Deltran I, Intercranial Pressure Kit (ICP)
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719020721 ()
  • H6719020720 ()
902-072

  • Vascular catheter flush valve, continuous
  • Invasive blood pressure transducer set
HI-LINE XS DISP.NEURO CUTTER I D1.8MM
Aesculap AG
GE431SU
In Commercial Distribution

  • 04046963171469 ()
GE431SU

  • Orthopaedic bur, single-use
HI-LINE XS DISP.NEURO CUTTER I D3.1MM
Aesculap AG
GE435SU
In Commercial Distribution

  • 04046963129149 ()
GE435SU

  • Orthopaedic bur, single-use
HI-LINE XS DISP.NEURO CUTTER I D2.3MM
Aesculap AG
GE434SU
Not in Commercial Distribution

  • 04046963129132 ()
GE434SU

  • Orthopaedic bur, single-use
Reusable I/A Handpiece, Curved Shaft
KIRWAN SURGICAL PRODUCTS LLC
13-5050
In Commercial Distribution

  • 00841019103487 ()


  • Surgical irrigation/aspiration handpiece, reusable
Reusable I/A Handpiece, Binkhorst Tip
KIRWAN SURGICAL PRODUCTS LLC
13-5020
In Commercial Distribution

  • 00841019103456 ()


  • Surgical irrigation/aspiration handpiece, reusable
Reusable I/A Handpiece, Straight Tip
KIRWAN SURGICAL PRODUCTS LLC
13-5000
In Commercial Distribution

  • 00841019103432 ()


  • Surgical irrigation/aspiration handpiece, reusable
HI-LINE XS DISP.ROSEN BURR I D2.0MM
AESCULAP, INC.
US393SU
Not in Commercial Distribution

  • 04046964602788 ()
US393SU

  • Burring power tool attachment
HI-LINE XS DISP.ROSEN BURR I D0.5MM
AESCULAP, INC.
US390SU
In Commercial Distribution

  • 04046964602757 ()
US390SU

  • Burring power tool attachment
HI-LINE XS DISP.DIAMOND BURR I+ D3.0MM
AESCULAP, INC.
US082SU
In Commercial Distribution

  • 04046964602559 ()
US082SU

  • Burring power tool attachment
HI-LINE XS DISP.DIAMOND BURR I+ D2.0MM
AESCULAP, INC.
US079SU
In Commercial Distribution

  • 04046964602528 ()
US079SU

  • Burring power tool attachment
HI-LINE XS DISP.DIAMOND BURR I D0.5MM
AESCULAP, INC.
US073SU
In Commercial Distribution

  • 04046964602481 ()
US073SU

  • Burring power tool attachment
HI-LINE XS DISP.DIAMOND BURR I D2.0MM
AESCULAP, INC.
US076SU
In Commercial Distribution

  • 04046964600197 ()
US076SU

  • Burring power tool attachment
PEDIPLATE GEN I IMPLANTS AND INSTRUMENTS
ORTHOPEDIATRICS CORP.
44-1010-2001
In Commercial Distribution

  • 00841132137246 ()
44-1010-2001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Angiographic Catheter, Multipurpose A I, 6F
Oscor Inc.
ANG506-0305
In Commercial Distribution

  • 10885672008502 ()
  • 00885672008505 ()

  • Maximum Recommended Guidewire 0.038 in
  • Length: 100 Centimeter
  • Recommended Pressure Limit: 1200 psi max.
  • Flow Rate: 50 mL/sec
ANG506-0305

  • Angiographic catheter, single-use
Angiographic Catheter, Multipurpose A I, 6F
Oscor Inc.
ANG506-0306
In Commercial Distribution

  • 10885672003378 ()
  • 00885672003371 ()

  • Maximum Recommended Guidewire 0.038 in
  • Flow Rate: 35 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Length: 110 Centimeter
ANG506-0306

  • Angiographic catheter, single-use
Angiographic Catheter, Multipurpose A I, 5F
Oscor Inc.
ANG505-0303
In Commercial Distribution

  • 10885672003361 ()
  • 00885672003364 ()

  • Length: 100 Centimeter
  • Flow Rate: 26 mL/sec
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
ANG505-0303

  • Angiographic catheter, single-use
Angiographic Catheter, Amplatz Left I, 6F
Oscor Inc.
ANG506-0106
In Commercial Distribution

  • 10885672003293 ()
  • 00885672003296 ()

  • Length: 110 Centimeter
  • Flow Rate: 36 mL/sec
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
ANG506-0106

  • Angiographic catheter, single-use
Angiographic Catheter, Amplatz Left I, 5F
Oscor Inc.
ANG505-0103
In Commercial Distribution

  • 10885672003286 ()
  • 00885672003289 ()

  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • Flow Rate: 24 mL/sec
  • Length: 100 Centimeter
ANG505-0103

  • Angiographic catheter, single-use
Tetric EvoCeram Refill 1x3g Bleach I
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
590329WW
In Commercial Distribution

  • 07615208446593 ()
  • 07615208300284 ()
  • DVIV590329WW1 ()
590329WW

  • Dental composite resin
Tetric EvoCeram Ref. 20x0.2g Bleach I
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
590348WW
In Commercial Distribution

  • 07615208454154 ()
  • 07615208300031 ()
  • 07615208469660 ()
  • DVIV590348WW1 ()
590348WW

  • Dental composite resin
LeFort I Plate, 9mm advancement, right
Stryker Leibinger GmbH & Co. KG
92-12709
In Commercial Distribution

  • 07613252096030 ()

  • Bar Length: 9.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-12709

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LeFort I Plate, 7mm advancement, right
Stryker Leibinger GmbH & Co. KG
92-12707
In Commercial Distribution

  • 07613252096023 ()

  • Bar Length: 7.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-12707

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LeFort I Plate, 5mm advancement, right
Stryker Leibinger GmbH & Co. KG
92-12705
In Commercial Distribution

  • 07613252096016 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 5.0 Millimeter
92-12705

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LeFort I Plate, 9mm advancement, left
Stryker Leibinger GmbH & Co. KG
92-11709
In Commercial Distribution

  • 07613252096009 ()

  • Bar Length: 9.0 Millimeter
  • Number of Screw Holes: 11.0 Holes
92-11709

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LeFort I Plate, 7mm advancement, left
Stryker Leibinger GmbH & Co. KG
92-11707
In Commercial Distribution

  • 07613252095996 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 7.0 Millimeter
92-11707

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LeFort I Plate, 5mm advancement, left
Stryker Leibinger GmbH & Co. KG
92-11705
In Commercial Distribution

  • 07613252095989 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 5.0 Millimeter
92-11705

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DBS PART I ELECTRODE INSERT PK
MEDLINE INDUSTRIES, INC.
DYNJ67360C
In Commercial Distribution

  • 40198459226572 ()
  • 10198459226571 ()
DYNJ67360C

  • General surgical procedure kit, non-medicated, single-use
I MICRO MESH N 90X90MM # 0.3MM
MCI-MEDICAL CONCEPT INNOVATION INC
A01.02.1012
In Commercial Distribution

  • 00811687032013 ()
A01.02.1012

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
I MICRO MESH N 120X120MM # 0.3MM
MCI-MEDICAL CONCEPT INNOVATION INC
A01.02.1013
In Commercial Distribution

  • 00811687032006 ()
A01.02.1013

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
I MICRO MESH N 40X40MM # 0.3MM
MCI-MEDICAL CONCEPT INNOVATION INC
A01.02.1011
In Commercial Distribution

  • 00811687031993 ()
A01.02.1011

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Audéo S SMART I (silver shadow)
Phonak AG
050-0965-C0
In Commercial Distribution

  • 07613275054086 ()
050-0965-C0

  • Air-conduction hearing aid, receiver-in-canal
Audéo S SMART I (chili red)
Phonak AG
050-0965-G5
In Commercial Distribution

  • 07613275054079 ()
050-0965-G5

  • Air-conduction hearing aid, receiver-in-canal
Audéo S SMART I (olive green)
Phonak AG
050-0965-G4
In Commercial Distribution

  • 07613275054062 ()
050-0965-G4

  • Air-conduction hearing aid, receiver-in-canal
Audéo S SMART I (ocean blue)
Phonak AG
050-0965-G3
In Commercial Distribution

  • 07613275054055 ()
050-0965-G3

  • Air-conduction hearing aid, receiver-in-canal
Naída S I UP Loaner (black)
Phonak AG
050-0995-06
In Commercial Distribution

  • 07613275045978 ()
050-0995-06

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (blue moon)
Phonak AG
050-0992-C9
In Commercial Distribution

  • 07613275044711 ()
050-0992-C9

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (savannah beauty)
Phonak AG
050-0992-B4
In Commercial Distribution

  • 07613275044704 ()
050-0992-B4

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (safari stripes)
Phonak AG
050-0992-B3
In Commercial Distribution

  • 07613275044698 ()
050-0992-B3

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (palladium/black)
Phonak AG
050-0992-70
In Commercial Distribution

  • 07613275044681 ()
050-0992-70

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (chestnut brown)
Phonak AG
050-0992-50
In Commercial Distribution

  • 07613275044674 ()
050-0992-50

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (purple transparent)
Phonak AG
050-0992-38
In Commercial Distribution

  • 07613275044650 ()
050-0992-38

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (blue transparent)
Phonak AG
050-0992-37
In Commercial Distribution

  • 07613275044643 ()
050-0992-37

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (red transparent)
Phonak AG
050-0992-36
In Commercial Distribution

  • 07613275044636 ()
050-0992-36

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (light blue)
Phonak AG
050-0992-34
In Commercial Distribution

  • 07613275044612 ()
050-0992-34

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (light pink)
Phonak AG
050-0992-33
In Commercial Distribution

  • 07613275044605 ()
050-0992-33

  • Air-conduction hearing aid, behind-the-ear
Naída S I UP (pure transparent)
Phonak AG
050-0992-13
In Commercial Distribution

  • 07613275044582 ()
050-0992-13

  • Air-conduction hearing aid, behind-the-ear
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