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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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Avenir® Müller - 00889024590823

No Description
Zimmer GmbH
01.06010.305
In Commercial Distribution

  • 00889024590823 ()

  • 5
01.06010.305

  • Uncoated hip femur prosthesis, modular

Avenir® Müller - 00889024590816

No Description
Zimmer GmbH
01.06010.205
In Commercial Distribution

  • 00889024590816 ()

  • 5
01.06010.205

  • Uncoated hip femur prosthesis, modular

Alloclassic® Zweymüller® - 00889024590373

No Description
Zimmer GmbH
01.00121.050
In Commercial Distribution

  • 00889024590373 ()

  • 5
01.00121.050

  • Press-fit hip femur prosthesis, modular

Alloclassic® Zweymüller® - 00889024590359

No Description
Zimmer GmbH
2845
In Commercial Distribution

  • 00889024590359 ()

  • 5
2845

  • Press-fit hip femur prosthesis, modular

CLS® Brevius® Kinectiv® - 00889024482531

No Description
Zimmer GmbH
01.00296.050
In Commercial Distribution

  • 00889024482531 ()

  • 5


  • Uncoated hip femur prosthesis, modular

Integra® - 10381780083771

Integra® Gruber Speculum, Oval End, Infant Size 5
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3724163
In Commercial Distribution

  • 10381780083771 ()

  • 5
  • Length: 35 Millimeter
  • Outer Diameter: 16 Millimeter
3724163

  • Ear speculum, reusable

Persona® The Personalized Knee® - 00889024632592

No Description
Zimmer, Inc.
42-5399-052-05
In Commercial Distribution

  • 00889024632592 ()

  • 5°
42-5399-052-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Persona® The Personalized Knee® - 00889024632578

No Description
Zimmer, Inc.
42-5399-051-25
In Commercial Distribution

  • 00889024632578 ()

  • 5°
42-5399-051-25

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Persona® The Personalized Knee® - 00889024632547

No Description
Zimmer, Inc.
42-5399-051-05
In Commercial Distribution

  • 00889024632547 ()

  • 5°
42-5399-051-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Fitmore® Hip Stem - 00889024431294

Fitmore Hip Stem B, Size 5
Zimmer GmbH
01.00551.205
In Commercial Distribution

  • 00889024431294 ()

  • 5


  • Coated hip femur prosthesis, modular

Fitmore® Hip Stem - 00889024431157

Fitmore Hip Stem A, Size 5
Zimmer GmbH
01.00551.105
In Commercial Distribution

  • 00889024431157 ()

  • 5


  • Coated hip femur prosthesis, modular

Alloclassic® Zweymüller® SLO - 00889024431041

Alloclassic®, SL stem, offset, uncemented, 5, taper 12/14
Zimmer GmbH
01.00121.050
In Commercial Distribution

  • 00889024431041 ()

  • 5


  • Press-fit hip femur prosthesis, modular

Avenir® - 00889024288355

Avenir® Stem lateral cemented 5
Zimmer GmbH
01.06010.305
In Commercial Distribution

  • 00889024288355 ()

  • 5


  • Uncoated hip femur prosthesis, modular

Avenir® - 00889024288263

Avenir® Standard stem cemented 5
Zimmer GmbH
01.06010.205
In Commercial Distribution

  • 00889024288263 ()

  • 5


  • Uncoated hip femur prosthesis, modular

Alloclassic® - 00889024301658

No Description
Zimmer GmbH
6868
In Commercial Distribution

  • 00889024301658 ()

  • 5
6868

  • Femoral stem prosthesis trial

Alloclassic® - 00889024301474

No Description
Zimmer GmbH
6825
In Commercial Distribution

  • 00889024301474 ()

  • 5
6825

  • Femoral stem prosthesis trial

Instrument Case - 00889024212671

No Description
Zimmer, Inc.
5967-01-50
In Commercial Distribution

  • 00889024212671 ()

  • 5 "
00-5967-001-50

  • Device sterilization/disinfection container, reusable

PEAK FX™LC CAP - 00887868037924

No Description
Biomet Orthopedics, LLC
8142-35-105
Not in Commercial Distribution

  • 00887868037924 ()

  • +5
814235105

  • Orthopaedic bone screw (non-sliding)

PEAK FX™LC CAP - 00887868037870

No Description
Biomet Orthopedics, LLC
8142-35-005
Not in Commercial Distribution

  • 00887868037870 ()

  • +5
814235005

  • Orthopaedic bone screw (non-sliding)

ATN®END CAP - 00887868064302

No Description
Biomet Orthopedics, LLC
9032-08-005
In Commercial Distribution

  • 00887868064302 ()

  • +5
903208005

  • Bone nail end-cap

Airway Armor® - 00840161304780

"Airway Armor 15pk Trial Kit 5 x Small 5 x Medium 5 x Large"
ZIRC DENTAL PRODUCTS, INC.
50Z960TRI
In Commercial Distribution

  • 00840161304780 ()


  • Dental throat shield

Snowden-Pencer - 10885403465567

Snowden-Pencer MIS SUCTION IRRIGATION HANDLE SPRING CAP PACK OF 5 5/PK X 5
STERIS CORPORATION
SIHSC-5
In Commercial Distribution

  • 70885403465569 ()
  • 10885403465567 ()
SIHSC5

  • Laparoscopic tissue manipulation forceps/working-channel

Snowden-Pencer - 70885403465576

Snowden-Pencer MIS ERGONOMIC SUCTION IRRIGATION HANDLE VALVE PACK OF 5 5/PK X 5
STERIS CORPORATION
ESIHV-5
In Commercial Distribution

  • 70885403465576 ()
  • 10885403465574 ()
ESIHV5

  • Surgical instrument handle, non-torque-limiting

Snowden-Pencer - 70885403465101

Snowden-Pencer MIS INCISION PICK 10MM REPLACEMENT BLADE PACK OF 5 5/PK X 5
STERIS CORPORATION
IPB10-5
In Commercial Distribution

  • 70885403465101 ()
  • 10885403465109 ()
IPB105

  • Laparoscopic trocar blade, reusable

Snowden-Pencer - 70885403465620

Snowden-Pencer MIS TROCAR SEALING CAP FOR 5.5MM PACK OF 5 5/PK X 5
STERIS CORPORATION
TSC5-5
In Commercial Distribution

  • 70885403465620 ()
  • 10885403465628 ()
TSC55

  • Laparoscopic trocar blade, reusable

Snowden-Pencer - 70885403465118

Snowden-Pencer MIS INCISION PICK 15MM REPLACEMENT BLADE PACK OF 5 5/PK X 5
STERIS CORPORATION
IPB20-5
In Commercial Distribution

  • 70885403465118 ()
  • 10885403465116 ()
IPB205

  • Laparoscopic trocar blade, reusable

X-Ray Marker with Ruler 5: 5, d=1.2mm, L=1230mm - 04049223108175

No Description
Eckert & Ziegler BEBIG GmbH
LLH02-22#04
Not in Commercial Distribution

  • 04049223108175 ()
LLH02-22

  • General-purpose brachytherapy system applicator, remote-afterloading

PAD, STERIS AMSCO ARM BOARD 26 X 5¼ X 5¼ - 00842430103094

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356039002
In Commercial Distribution

  • 00842430103094 ()
CT-356039002

  • Operating table mattress, basic

UbiqVue Multiparameter - B353UB25501

2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

LifeSignal - B353LP11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system

ImagineMed - B353IM12101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution

  • B353IM12103 ()
  • B353IM12102 ()
  • B353IM12101 ()


  • Electrocardiography telemetric monitoring system

ImagineMIC - B353IM11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system

CORVITALS - B353CV12451

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system

Cherish Serenity - B353CS124501

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution

  • B353CS124502 ()
  • B353CS124501 ()
  • B353CS124503 ()


  • Electrocardiography telemetric monitoring system

WEB Aneurysm Embolization System - 00854111006082

WEB 21 SL 5x5
SEQUENT MEDICAL, INC.
W4-5-5
In Commercial Distribution

  • 00854111006082 ()

  • 5 x 5 mm
FGA25050-050

  • Neurovascular embolization coil

n/a - 04048844590079

MK femoral spacer distal rl/lm
implantcast GmbH
5722050500
In Commercial Distribution

  • 04048844590079 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
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