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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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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 - 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 - 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

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

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 - 04048844214494

MK femoral spacer posterior incl. screw
implantcast GmbH
57225005
In Commercial Distribution

  • 04048844214494 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge

n/a - 04048844152420

MK femoral spacer distal rl/lm incl. screw
implantcast GmbH
57220505
In Commercial Distribution

  • 04048844152420 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge

n/a - 04048844590079

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

  • 04048844590079 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge

n/a - 04048844589769

MK femoral spacer distal ll/rm
implantcast GmbH
5722550500
In Commercial Distribution

  • 04048844589769 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge

n/a - 04048844589479

MK femoral spacer posterior
implantcast GmbH
5722500500
In Commercial Distribution

  • 04048844589479 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge

n/a - 04048844214623

MK femoral spacer distal ll/rm incl. screw
implantcast GmbH
57225505
In Commercial Distribution

  • 04048844214623 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge

IMMCO DIAGNOSTICS - 00845714002168

ANA Pattern Control Panel II
IMMCO DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • 00845714002168 ()

  • 5 x .5 ml
1602

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

MILLER RASPATORY - 00192896047792

MILLER RASPATORY DOUBLE ENDED SERRATED TIP
SONTEC INSTRUMENTS, INC.
1100-490
In Commercial Distribution

  • 00192896047792 ()

  • 5/5 Millimeter Tips
  • Length: 7.125 Inch
1100-490

  • Bone file/rasp, manual, reusable

HEDY DENTAL DAM - 10686864060427

HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Medium - Blue
AMD Medicom Inc
320DNB-5M
In Commercial Distribution

  • 00686864060420 ()
  • 10686864060427 ()
  • 20686864060424 ()

  • 5 X 5 Inch
320DNB-5M

  • Rubber dam, non-latex

HEDY DENTAL DAM - 10686864060410

HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Heavy - Blue
AMD Medicom Inc
320DNB-5H
In Commercial Distribution

  • 00686864060413 ()
  • 10686864060410 ()
  • 20686864060417 ()

  • 5 X 5 Inch
320DNB-5H

  • Rubber dam, non-latex

HEDY DENTAL DAM - 10686864060311

HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Thin - Blue
AMD Medicom Inc
310DB-5T
In Commercial Distribution

  • 00686864060314 ()
  • 10686864060311 ()

  • 5 X 5 Inch
310DB-5T

  • Rubber dam, Hevea-latex

HEDY DENTAL DAM - 10686864060304

HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Medium - Blue
AMD Medicom Inc
310DB-5M
In Commercial Distribution

  • 00686864060307 ()
  • 10686864060304 ()

  • 5 X 5 Inch
310DB-5M

  • Rubber dam, Hevea-latex

HEDY DENTAL DAM - 10686864060298

HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Heavy - Blue
AMD Medicom Inc
310DB-5H
In Commercial Distribution

  • 00686864060291 ()
  • 10686864060298 ()

  • 5 x 5 Inch
310DB-5H

  • Rubber dam, Hevea-latex
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