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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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DURAMER® - M68438212846001

DURAMER®DOME/FIN SHELL LINER 46mm OD 28mm ID
Microport Orthopedics Inc.
3821284600
In Commercial Distribution

  • 3821284600 ()
  • M68438212846001 ()

  • Lumen/Inner Diameter: 28 Millimeter
3821284600

  • Non-constrained polyethylene acetabular liner

N/A - 10841898129704

Webster Fixed Curve w/Auto ID Diagnostic EP Catheter 5F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898129704 ()
F5ADP282CT

  • Cardiac mapping catheter, percutaneous, reprocessed

BOJRAB TINY TRIUNE - 10844505007907

BOJRAB TINY TRIUNE 0.76MM ID - SILICONE, 80 DUROMETER - 5 PACK
Grace Medical, Inc.
510-511
Not in Commercial Distribution

  • 10844505007907 ()


  • Tympanostomy tube

N/A - 10841898121166

Webster Fixed Curve with Auto ID Diagnostic EP Catheter, 6F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898121166 ()
F6QF005CT

  • Cardiac mapping catheter, percutaneous, reprocessed

N/A - 10841898121067

Webster Fixed Curve w/Auto ID Diagnostic EP Catheter 6F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898121067 ()
F6QA005CT

  • Cardiac mapping catheter, percutaneous, reprocessed

N/A - 10841898121005

Webster Fixed Curve w/Auto ID Diagnostic EP Catheter, 5F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898121005 ()
F5QF005CT

  • Cardiac mapping catheter, percutaneous, reprocessed

N/A - 10841898114090

Lasso w/Auto ID Non NAV Diagnostic EP Catheter, 7F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898114090 ()
D7L2015CT

  • Cardiac mapping catheter, percutaneous, reprocessed

N/A - 10841898114052

Lasso w/Auto ID Non NAV Diagnostic EP Catheter 7F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898114052 ()
D7L1020CT

  • Cardiac mapping catheter, percutaneous, reprocessed

N/A - 10841898114038

Lasso w/Auto ID Non NAV Diagnostic EP Catheter, 7F
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898114038 ()
D7L1015CT

  • Cardiac mapping catheter, percutaneous, reprocessed

Ring Cushions - 10850013699251

Single Ring Cushion 8" OD X 3.5" ID X 3"
GENEVA HEALTHCARE, LLC
SYK41-252-11
In Commercial Distribution

  • 10850013699251 ()
  • 00850013699254 ()
SYK41-252-11

  • Freestanding patient positioner, single-use

Ring Cushions - 10850013699084

Single Ring Cushion 9" OD X 4.5" ID X 2"
GENEVA HEALTHCARE, LLC
SYK41-213-11
In Commercial Distribution

  • 10850013699084 ()
  • 00850013699087 ()
SYK41-213-11

  • Freestanding patient positioner, single-use

V. Mueller - 10885403247040

V. Mueller INSTRUMENT CARE ID ROLL TAPE 9 COLOR ASSORTMENT
STERIS CORPORATION
HS7205-RL
Not in Commercial Distribution

  • 10885403247040 ()
HS7205RL

  • Surgical instrument track identification tape

LOQTEQ® - 04042409234231

Drill guide for round hole LOQTEQ 3.5, ID 2.4, green
aap Implantate AG
IU 8166-30
In Commercial Distribution

  • 04042409234231 ()


  • Surgical drill guide, reusable

LOQTEQ® - 04042409213076

Drill guide for gliding hole LOQTEQ 4.5, ID 3.9, red
aap Implantate AG
IU 8167-10
In Commercial Distribution

  • 04042409213076 ()


  • Surgical drill guide, reusable

LOQTEQ® - 04042409208140

Drill guide for round hole LOQTEQ 3.5, ID 2.8, blue
aap Implantate AG
IU 8166-20
In Commercial Distribution

  • 04042409208140 ()


  • Surgical drill guide, reusable

KENOREX - 10852244007379

PEEP VALVE DISPOSABLE 5-20 CMS WATER PRESSURE, 30 MM ID
KENTRON HEALTHCARE, INC.
712320
In Commercial Distribution

  • 00852244007372 ()
  • 10852244007379 ()
712320

  • PEEP valve, single-use

Newport Medical - 10884521540606

Universal (22 mm ID )Abbreviated (Partial) J Ventilation Breathing Circuit
Newport Medical Instruments, Inc.
BCD40801P
In Commercial Distribution

  • 10884521644694 ()
  • 10884521540606 ()

  • Inside Diameter, 22, mm;


  • Ventilator breathing circuit, reusable

Newport Medical - 10884521540514

Pediatric (15 mm ID) Abbreviated (Partical) J Ventilation Breathing Circuit
Newport Medical Instruments, Inc.
BCD20801P
Not in Commercial Distribution

  • 20884521540511 ()
  • 10884521540514 ()

  • Inside Diameter, 15, mm;


  • Ventilator breathing circuit, reusable

CLAMP FORCEPS - B974VAS140S02

VAS. DEFERENCE CLAMP FORCEPS 14CM, SATIN, ID 3.25mm, OD 5.45mm
DR.FRIGZ INTERNATIONAL(PVT)LTD,
CLAMP FORCEPS
In Commercial Distribution

  • B974VAS140S02 ()

  • Length: 14 Centimeter
VAS140S

  • Dressing/utility forceps, scissors-like, single-use

Smart Correction - B56250101824AWB0

Dual Hole 1/3 Ring, 240mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-24A-WB
Not in Commercial Distribution

  • B56250101824AWB0 ()
50-1018-24A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101822AWB0

Dual Hole 1/3 Ring, 225mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-22A-WB
Not in Commercial Distribution

  • B56250101822AWB0 ()
50-1018-22A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101821AWB0

Dual Hole 1/3 Ring, 210mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-21A-WB
Not in Commercial Distribution

  • B56250101821AWB0 ()
50-1018-21A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101819AWB0

Dual Hole 1/3 Ring, 195mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-19A-WB
Not in Commercial Distribution

  • B56250101819AWB0 ()
50-1018-19A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101818AWB0

Dual Hole 1/3 Ring, 180mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-18A-WB
Not in Commercial Distribution

  • B56250101818AWB0 ()
50-1018-18A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101816AWB0

Dual Hole 1/3 Ring, 165mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-16A-WB
Not in Commercial Distribution

  • B56250101816AWB0 ()
50-1018-16A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101815AWB0

Dual Hole 1/3 Ring, 150mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-15A-WB
Not in Commercial Distribution

  • B56250101815AWB0 ()
50-1018-15A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101813AWB0

Dual Hole 1/3 Ring, 135mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-13A-WB
Not in Commercial Distribution

  • B56250101813AWB0 ()
50-1018-13A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101812AWB0

Dual Hole 1/3 Ring, 120mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-12A-WB
Not in Commercial Distribution

  • B56250101812AWB0 ()
50-1018-12A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101810AWB0

Dual Hole 1/3 Ring, 105mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1018-10A-WB
Not in Commercial Distribution

  • B56250101810AWB0 ()
50-1018-10A-WB

  • External orthopaedic fixation system, single-use

Smart Correction - B56250101724AWB0

Dual Hole 2/3 Ring, 240mm ID, Aluminum, Black, Non-Sterile
Wishbone Medical, Inc.
50-1017-24A-WB
Not in Commercial Distribution

  • B56250101724AWB0 ()
50-1017-24A-WB

  • External orthopaedic fixation system, single-use
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