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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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Gabriel Feeding Tube with Balloon - 00860000931335

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution

  • 10860000931332 ()
  • 00860000931335 ()

  • Catheter Gauge: 8 French
  • 8 FR (3.3mm)X 32”(80cm)
GFTB 508

  • Nasogastric feeding tube

Reusable Probe with Irrigation Holes - 00607915117139

Reusable Probe with Irrigation Holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6211
Not in Commercial Distribution

  • 00607915117139 ()

  • Length: 45 Centimeter
  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable

ECC Circulatory Pk with Quadrox - 00607567207561

BEQ-HMOD 70000 USA Adult Quadrox Softshell venous Reser. 1900ml with connector Gas Filter
DATASCOPE CORP.
BEQ-TOP 47501
Not in Commercial Distribution

  • 00607567207561 ()
709000031

  • Cardiopulmonary bypass system blood tubing set

Adult Pack with Quadrox iD - 00607567205536

BEQ-HMOD 70000-USA Adult Quadrox iD, Better Bladder 3/8, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Gas Filter
DATASCOPE CORP.
BEQ-TOP 13505
Not in Commercial Distribution

  • 00607567205536 ()
701065817

  • Cardiopulmonary bypass system blood tubing set

Pediatric ECC Pack with QPID - 00607567205192

BEQ-HMOD 30000-USA Pediatric Quadrox Softshell Venous Reser 800 ml Better Bladder BEQ-RF32 RotaFlow CDI Sat Cell 1/4" Blood Microfilter Systes Prebypass filter w/o Vent Posous Media Gas Filter Temperature Probe
DATASCOPE CORP.
BEQ-TOP 31000
Not in Commercial Distribution

  • 00607567205192 ()
701052843

  • Cardiopulmonary bypass system blood tubing set

Liver TX with VHK 31000 - 00607567205130

BO-VHK 31000 Venous Res. Pediatric (MACE), BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 16403
Not in Commercial Distribution

  • 00607567205130 ()
701065315

  • Cardiopulmonary bypass system blood tubing set

ECC Pack with Quadrox iD - 00607567203075

BEQ-HMOD 70000 Softshell venous reser Better Bladder BEQ-RF32 CDI Sat Cell Blood Microfilter System Prebypass Filter
DATASCOPE CORP.
BEQ-TOP 35300
Not in Commercial Distribution

  • 00607567203075 ()
70105506

  • Cardiopulmonary bypass system blood tubing set

Pediatric ECC Pack with QPid - 00607567202580

BEQ HMOD 30000 BEQ-RF32 Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 6604
Not in Commercial Distribution

  • 00607567202580 ()
701052163

  • Cardiopulmonary bypass system blood tubing set

Straight Pin with Shoulder 3.2x90 - 09348215061937

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-162-019
In Commercial Distribution

  • 09348215061937 ()


  • Fluted surgical drill bit, reusable

Straight Pin with Shoulder 3.2x70 - 09348215061920

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-162-018
In Commercial Distribution

  • 09348215061920 ()


  • Fluted surgical drill bit, reusable

Reusable Probe with Pool Tip - 00607915117085

Reusable Probe with Pool Tip.
APPLIED MEDICAL RESOURCES CORPORATION
C6205
Not in Commercial Distribution

  • 00607915117085 ()

  • Length: 33 Centimeter
  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable

Respiratory ECC Pack with QPiD - 00607567213449

BEQ-HMOD 30000-USA Pediatric Quadrox iD
DATASCOPE CORP.
BEQ-TOP 8512
In Commercial Distribution

  • 00607567213449 ()
709000624

  • Cardiopulmonary bypass system blood tubing set

Skull Pin with big tip - 04251269201028

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269201028 ()
114096

  • MRI system coil, radio-frequency

Brainlab Interface Rotating, with Marking - 04251269204715

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269204715 ()
113382

  • MRI system coil, radio-frequency

Bolus Material 20x20x1 with film - 09120074396531

No Description
IT-V Medizintechnik GmbH
P10107-653
Not in Commercial Distribution

  • 09120074396531 ()


  • Radiological whole-body positioner

Bolus Material 20x20x0,5 with film - 09120074396524

No Description
IT-V Medizintechnik GmbH
P10107-652
Not in Commercial Distribution

  • 09120074396524 ()


  • Radiological whole-body positioner

Multi wrench with ISO adapter - 09321502019644

N/A
Cochlear Bone Anchored Solutions AB
92143
In Commercial Distribution

  • 09321502019644 ()
92143

  • General external orthopaedic fixation system implantation kit, reusable

AuDX PRO Device with touchscreen - 04260223143298

AuDX PRO branded Sentiero
PATH medical GmbH
100098-AUP
In Commercial Distribution

  • 04260223143298 ()


  • Evoked-potential audiometer

NavPro ONE Device with touchscreen - 04260223143311

NavPRO One branded Sentiero Advanced
PATH medical GmbH
100360-NPO
In Commercial Distribution

  • 04260223143311 ()


  • Evoked-potential audiometer

SKORE Thin Condoms with Flavors - 08906007135511

The SKORE Thin Condoms with flavors - SKORE SKINTHIN condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, silicone oil with Zeus odor masker male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE SKINTHIN natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE SKINTHIN
In Commercial Distribution

  • 08906007135528 ()
  • 08906007135511 ()
  • 08906007135535 ()
  • 08906007135542 ()


  • Basic male condom, Hevea-latex

SKORE Thin Condoms with Flavors - 08906007135474

The SKORE Thin Condoms with Flavors - SKORE NOTHING Chocolate condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, Chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE NOTHING Chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE NOTHING Chocolate
In Commercial Distribution

  • 08906007135481 ()
  • 08906007135474 ()
  • 08906007135498 ()
  • 08906007135504 ()


  • Basic male condom, Hevea-latex

ECG-Connection Cable with isolated Tips - 04260166370294

No Description
Stockert GmbH
S7015
In Commercial Distribution

  • 04260166370294 ()


  • Electrical catheter connection cable, reusable

coflex Trial with wings, 14mm - 04260148898839

No Description
Paradigm Spine GmbH
UCT00014
In Commercial Distribution

  • 04260148898839 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex Trial with wings, 8mm - 04260148898808

No Description
Paradigm Spine GmbH
UCT00008
In Commercial Distribution

  • 04260148898808 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex trial slider with wings - 04260148897795

No Description
Paradigm Spine GmbH
UXT10000
In Commercial Distribution

  • 04260148897795 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

coflex-F Punching pliers with guiding - 04260148897665

No Description
Paradigm Spine GmbH
RAT20101
In Commercial Distribution

  • 04260148897665 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Cannulated Handle with Ratchet - 04260148896187

No Description
Paradigm Spine GmbH
HAT40120
In Commercial Distribution

  • 04260148896187 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Needle Holder Castroviejo With Lock - 05060480408159

No Description
BLINK MEDICAL LIMITED
90-7001
In Commercial Distribution

  • 05060480408159 ()
  • 05060480402652 ()


  • Suturing needle holder, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705531532

No Description
MAXILL, INC.
6070553153
In Commercial Distribution

  • D89260705531530 ()
  • D89260705531532 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705531531

No Description
MAXILL, INC.
6070553153
In Commercial Distribution

  • D89260705531530 ()
  • D89260705531531 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705531522

No Description
MAXILL, INC.
6070553152
In Commercial Distribution

  • D89260705531520 ()
  • D89260705531522 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705531521

No Description
MAXILL, INC.
6070553152
In Commercial Distribution

  • D89260705531520 ()
  • D89260705531521 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705530992

No Description
MAXILL, INC.
6070553099
In Commercial Distribution

  • D89260705530990 ()
  • D89260705530992 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705530991

No Description
MAXILL, INC.
6070553099
In Commercial Distribution

  • D89260705530990 ()
  • D89260705530991 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705530982

No Description
MAXILL, INC.
6070553098
In Commercial Distribution

  • D89260705530980 ()
  • D89260705530982 ()


  • Dental suction system cannula, single-use

SALIVA EJECTORS WITH AFFIXED TIP - D89260705530981

No Description
MAXILL, INC.
6070553098
In Commercial Distribution

  • D89260705530980 ()
  • D89260705530981 ()


  • Dental suction system cannula, single-use

COMBO THREADERS WITH DENTAL FLOSS - D89260705411281

No Description
MAXILL, INC.
6070541128
In Commercial Distribution

  • D89260705411282 ()
  • D89260705411281 ()
  • D89260705411283 ()
  • D89260705411280 ()


  • Dental floss

Washers with Rubber Ring - Brass - 00848530001162

Washers with Rubber Ring - Brass (50 Washers)
SUNSET HEALTHCARE SOLUTIONS, INC.
HCS166840
In Commercial Distribution

  • 00848530001162 ()
  • 10848530001169 ()

  • 800cc
HCS166840

  • Surgical suction system collection container, single-use

Suction Kit with XL Tube - 00848530081669

This Kit Contains: 1 RES023 Suction Canister, 1 RES024XL Suction Tubing Connector - 16in, 1 RES025 Suction Tubing - 6ft, 1 RES028 Elbow Connector, 1 BF3812 Bacteria Filter.
SUNSET HEALTHCARE SOLUTIONS, INC.
RES026-EXL
In Commercial Distribution

  • 00848530081669 ()
RES026-EXL

  • Secretion suction kit

Christmas Tree Connectors - with Swivel - 00848530080877

Christmas Tree Connectors - with Swivel (50/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES002-50
In Commercial Distribution

  • 00848530080877 ()
  • 10848530080874 ()
RES002-50

  • Low-pressure tubing connector, reusable

Washers with Rubber Ring - Brass - 00848530061227

Washers with Rubber Ring - Brass (50/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES035-50
In Commercial Distribution

  • 00848530061227 ()
  • 10848530061224 ()

  • 800cc
RES035-50

  • Surgical suction system collection container, single-use

Washers with Rubber Ring - Aluminum - 00848530060633

Washers with Rubber Ring - Aluminum (25/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES036
In Commercial Distribution

  • 00848530060633 ()
  • 10848530060630 ()

  • 800cc
RES036

  • Surgical suction system collection container, single-use

Christmas Tree Connector - with Swivel - 00848530060046

Christmas Tree Connector - with Swivel (1/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES002-1
In Commercial Distribution

  • 00848530060046 ()
RES002-1

  • Low-pressure tubing connector, reusable

Christmas Tree Connectors - with Swivel - 00848530060039

Christmas Tree Connectors - with Swivel (10/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES002
In Commercial Distribution

  • 00848530060039 ()
  • 10848530060036 ()
RES002

  • Low-pressure tubing connector, reusable

SecureSafe Syringe With Safety Needle - 00616784893228

No Description
Dynarex Corporation
8932
In Commercial Distribution

  • 00616784893228 ()
  • 00616784893211 ()


  • Insulin syringe/needle, safety

SecureSafe Syringe With Safety Needle - 00616784893129

No Description
Dynarex Corporation
8931
In Commercial Distribution

  • 00616784893129 ()
  • 00616784893112 ()


  • Insulin syringe/needle, safety

SecureSafe Syringe With Safety Needle - 00616784893020

No Description
Dynarex Corporation
8930
In Commercial Distribution

  • 00616784893020 ()
  • 00616784893013 ()


  • Insulin syringe/needle, safety

SecureSafe Syringe With Safety Needle - 00616784892924

No Description
Dynarex Corporation
8929
In Commercial Distribution

  • 00616784892924 ()
  • 00616784892917 ()


  • Insulin syringe/needle, safety

SecureSafe Syringe With Safety Needle - 00616784892726

No Description
Dynarex Corporation
8927
In Commercial Distribution

  • 00616784892726 ()
  • 00616784892719 ()


  • Insulin syringe/needle, safety

SecureSafe Syringe With Safety Needle - 00616784892627

No Description
Dynarex Corporation
8926
In Commercial Distribution

  • 00616784892627 ()
  • 00616784892610 ()


  • Insulin syringe/needle, safety
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