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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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SOOTHE-GUARD® - D0036619053001

Soothe-Guard® Adult Pano Cape .35mm - Light Blue
Dentsply International Inc.
661905300
In Commercial Distribution

  • D0036619053001 ()
661905300

  • Radiation shielding apron

SOOTHE-GUARD® - D0036619050001

Soothe-Guard® Adult Apron with Collar .35mm - Light Blue
Dentsply International Inc.
661905000
In Commercial Distribution

  • D0036619050001 ()
661905000

  • Radiation shielding apron

SOOTHE-GUARD® - D0036618053001

Soothe-Guard® Adult Pano Cape .35mm - Navy Blue
Dentsply International Inc.
661805300
In Commercial Distribution

  • D0036618053001 ()
661805300

  • Radiation shielding apron

SOOTHE-GUARD® - D0036618050001

Soothe-Guard® Adult Apron with Collar .35mm- Navy Blue
Dentsply International Inc.
661805000
In Commercial Distribution

  • D0036618050001 ()
661805000

  • Radiation shielding apron

SOOTHE-GUARD® - D0036618047001

Soothe-Guard® Child Apron with Collar .35mm - Navy Blue
Dentsply International Inc.
661804700
In Commercial Distribution

  • D0036618047001 ()
661804700

  • Radiation shielding apron

DreamStation BiPAP AVAPS - 00606959045774

DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
Respironics, Inc.
DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU
In Commercial Distribution

  • 00606959045774 ()
AUX1131T15C

  • Portable electric ventilator

Axiom® SeroVac® - M6652150

SeroVac® Drain, With Needle, With Connection Tubing, With Vacuum Tubes and Connector
AXIOM MEDICAL, INCORPORATED
215
In Commercial Distribution

  • M6652153 ()
  • M6652151 ()
  • M6652150 ()

  • Length: 5.2 Inch
  • 14 gauge
  • Total Volume: 10 Milliliter


  • Closed-wound drain, non-bioabsorbable

Axiom® SeroVac® - M6652130

SeroVac® Drain, With Needle, With Connection Tubing, With Vacuum Tubes and Connector
AXIOM MEDICAL, INCORPORATED
213
In Commercial Distribution

  • M6652133 ()
  • M6652131 ()
  • M6652130 ()

  • Total Volume: 10 Milliliter
  • 14 gauge
  • Length: 3.5 Inch


  • Closed-wound drain, non-bioabsorbable

JOBST Elvarex - 04019702303100

Elvarex 2/Glove to elbow/With Finger, with Thumb/Slip form with volant
BSN-Jobst GmbH
77359-00007-00
In Commercial Distribution

  • 04019702303100 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

Accu-Patch Gold Plated type with Tan color tape with Latex - 04955114013155

No Description
SAKAMURA KENKYUSHO, K.K.
8010141
In Commercial Distribution

  • 04955114013155 ()


  • Ear microsystem seed/pellet

Accu-Patch Stainless steel type with Tan color tape with Latex - 04955114013148

300 units in single package
SAKAMURA KENKYUSHO, K.K.
8010140
In Commercial Distribution

  • 04955114013148 ()


  • Ear microsystem seed/pellet

Magrain Gold with Tan Color Tape, without pack, with Latex - 04955114013124

300 units in single package
SAKAMURA KENKYUSHO, K.K.
8010011
In Commercial Distribution

  • 04955114013124 ()


  • Ear microsystem seed/pellet

Magrain Silver with Tan Color Tape, without pack, with Latex - 04955114013117

300 units in single package
SAKAMURA KENKYUSHO, K.K.
8010010
In Commercial Distribution

  • 04955114013117 ()


  • Ear microsystem seed/pellet

Transport Kit with Pediatric Elongated Non-Rebrreather Mask with Safety Vent - 00709078004827

No Description
WESTMED, INC.
9443
In Commercial Distribution

  • 10709078004824 ()
  • 00709078004827 ()


  • Oxygen administration tubing

Transport Kit with Adult Elongated Non-Rebreather Mask with Safety Vent - 00709078004810

No Description
WESTMED, INC.
9442
In Commercial Distribution

  • 10709078004817 ()
  • 00709078004810 ()


  • Oxygen administration tubing

Cover plate III with centered cylinder hole, with fixation screws - 00816389023949

No Description
Varian Medical Systems Deutschland GmbH
GM11007010
In Commercial Distribution

  • 00816389023949 ()
GM11007010

  • General-purpose brachytherapy system applicator, remote-afterloading

Cover plate IV with de-centered cylinder hole, with fixation screws - 00816389023932

No Description
Varian Medical Systems Deutschland GmbH
GM11007000
In Commercial Distribution

  • 00816389023932 ()
GM11007000

  • General-purpose brachytherapy system applicator, remote-afterloading

LabChoice Culture Tubes,With Dual Position Cap,Polystyrene,With Graduation - 00840117337213

Markings - 17 x 100 mm, STERILE-R
Dynarex Corporation
42306
In Commercial Distribution

  • 00810180841146 ()
  • 00840117337213 ()
  • 00840117335042 ()


  • Culture tube

TURP tubing set with Laser Cooling line – Use with Gravity - 03700512900993

No Description
Promepla
ONGR2001ST12
In Commercial Distribution

  • 03700512920991 ()
  • 03700512910992 ()
  • 03700512900993 ()
ONGR2001ST12

  • Surgical irrigation/aspiration tubing set

X-MOUNT CAMERA ADAPTER WITH FLANGE-MOUNT, USE WITH CAMCORDERS AND POINT-AND-SHOO - 00810040251351

No Description
GLOBAL SURGICAL CORPORATION
M 528X
In Commercial Distribution

  • 00810040251351 ()


  • General-purpose surgical microscope

ATRAMAT - 07500142013126

ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 3-0 EP 2, 70 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
PGC25
In Commercial Distribution

  • 07500142113123 ()
  • 07500142013126 ()
  • 07500142313127 ()

  • Length: 19 Millimeter
  • USP 3-0 EP 2
PE1903-B

  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

ATRAMAT - 07500142003974

ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 45 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
NYLON
In Commercial Distribution

  • 07500142103971 ()
  • 07500142003974 ()
  • 07500142203978 ()

  • Length: 24 Millimeter
  • USP 0 EP 3,5
CE2441-N

  • Nylon suture, non-bioabsorbable, monofilament

ATRAMAT - 07500142003752

ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 0 EP 3,5, 75 CM NEEDLE C-26 REVERSE CUTTING 26 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
POLYPROPILENE
In Commercial Distribution

  • 07500142103759 ()
  • 07500142003752 ()
  • 07500142203756 ()

  • Length: 26 Millimeter
  • USP 0 EP 3,5
C2661-75

  • Polyolefin/fluoropolymer suture, monofilament

ATRAMAT - 07500142002052

ATRAMAT PLAIN GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE R-26 REGULAR TAPER POINT 26 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
PLAIN GUT
In Commercial Distribution

  • 07500142102059 ()
  • 07500142002052 ()
  • 07500142202056 ()

  • Length: 26 Millimeter
  • USP 4-0 EP 2
R2624-75

  • Catgut suture, chromic

ATRAMAT - 07500142001826

ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 4-0 EP 2, 75 CM NEEDLE F-17 FINE TAPER POINT 17 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
CHROMIC GUT
In Commercial Distribution

  • 07500142101823 ()
  • 07500142001826 ()
  • 07500142201820 ()

  • Length: 17 Millimeter
  • USP 4-0 EP 2
F1714-75

  • Catgut suture, chromic

ATRAMAT - 07500142001437

ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 2 EP 6, 75 CM NEEDLE G-37 HEAVY TAPER POINT 37 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
CHROMIC GUT
In Commercial Distribution

  • 07500142101434 ()
  • 07500142001437 ()
  • 07500142201431 ()

  • Length: 37 Millimeter
  • USP 2 EP 6
G3719-75

  • Catgut suture, chromic

ATRAMAT - 07500142001284

ATRAMAT PGA SURGICAL SUTURE VIOLET USP 1 EP 4, 75 CM NEEDLE G-30 HEAVY TAPER POINT 30 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
PGA
In Commercial Distribution

  • 07500142101281 ()
  • 07500142001284 ()
  • 07500142301285 ()

  • Length: 30 Millimeter
  • USP 1 EP 4
G3098-75

  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

ATRAMAT - 07500142001277

ATRAMAT PGA SURGICAL SUTURE VIOLET USP 5-0 EP 1, 75 CM NEEDLE F-17 FINE TAPER POINT 17 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
PGA
In Commercial Distribution

  • 07500142101274 ()
  • 07500142001277 ()
  • 07500142301278 ()

  • Length: 17 Millimeter
  • USP 5-0 EP 1
F1795-75

  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

ATRAMAT - 07500142001079

ATRAMAT PGA SURGICAL SUTURE VIOLET USP 2-0 EP 3, 75 CM NEEDLE G-40 HEAVY TAPER POINT 40 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
PGA
In Commercial Distribution

  • 07500142101076 ()
  • 07500142001079 ()
  • 07500142301070 ()

  • Length: 40 Millimeter
  • USP 2-0 EP 3
G4092-75

  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial

ATRAMAT - 07500142000706

No Description
Internacional Farmacéutica, S.A. de C.V.
CHROMIC GUT
In Commercial Distribution

  • 07500142100703 ()
  • 07500142000706 ()
  • 07500142200700 ()

  • Length: 37 Millimeter
  • USP 3-0 EP 3
G3713-75

  • Rigid optical intracranial/spinal endoscope, single-use

ATRAMAT - 07500142000270

ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 0 EP 4, 75 CM NEEDLE R-37 REGULAR TAPER POINT 37 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
CHROMIC GUT
In Commercial Distribution

  • 07500142100277 ()
  • 07500142000270 ()
  • 07500142200274 ()

  • Length: 37 Millimeter
  • USP 0 EP 4
R3711-75

  • Catgut suture, chromic

ATRAMAT - 07500142000119

ATRAMAT CHROMIC GUT SURGICAL SUTURE USP 2-0 EP 3,5, 75 CM NEEDLE R-37 REGULAR TAPER POINT 37 MM 1/2 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
CHROMIC GUT
In Commercial Distribution

  • 07500142100116 ()
  • 07500142000119 ()
  • 07500142200113 ()

  • Length: 37 Millimeter
  • USP 2-0 EP 3,5
R3712-75

  • Catgut suture, chromic

FitLife - 00606959023109

FitLife Mask with Standard Elbow, with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with SE, with Headgear, XLarge, JP
Not in Commercial Distribution

  • 00606959023109 ()
1089997

  • CPAP/BPAP face mask, reusable

FitLife - 00606959023079

FitLife Mask with Standard Elbow, with Headgear, Extra Large, International
Respironics, Inc.
FitLife Mask with SE, with Headgear, XLarge, INTL
In Commercial Distribution

  • 00606959023079 ()
1089995

  • CPAP/BPAP face mask, reusable

REMstar SE - 00606959020078

REMstar SE with Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE with Humidifier, with SD Slot, CA
Not in Commercial Distribution

  • 00606959020078 ()
CA221HS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar SE - 00606959020047

REMstar SE with Humidifier, with SD Slot, AH
Respironics, Inc.
REMstar SE with Humidifier, with SD Slot, AH
Not in Commercial Distribution

  • 00606959020047 ()
AH220HS

  • Home CPAP unit
  • Heated respiratory humidifier

REMstar SE - 00606959036918

REMstar SE with Humidifier, with SD Slot, International
Respironics, Inc.
REMstar SE with HUMIDIFIER, with SD Slot, INTL
In Commercial Distribution

  • 00606959036918 ()
IN221HS

  • Home CPAP unit
  • Heated respiratory humidifier

DreamStation - 00606959034297

DreamStation BiPAP Pro with Humidifier and WiFi, American Home Patient
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with WiFi, AHP
Not in Commercial Distribution

  • 00606959034297 ()
AHX600H11W

  • Home BPAP unit

AF541 - 00606959024670

AF541 with Standard Elbow, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, X-LARGE
In Commercial Distribution

  • 30606959024671 ()
  • 00606959024670 ()
1121081

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024663

AF541 Mask with Standard Elbow, with CapStrap, Large
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959024664 ()
  • 00606959024663 ()
1121080

  • CPAP/BPAP face mask, single-use
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