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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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Christmas Tree Connectors - with Swivel - 00848530060053

Christmas Tree Connectors - with Swivel (100/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES002-100
In Commercial Distribution

  • 00848530060053 ()
  • 10848530060050 ()
RES002-100

  • 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

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

ADVIA 2120i with SAA Autosampler - 00630414019789

ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD

ADVIA 2120i with DAA Autosampler - 00630414019772

ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH DUAL ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219529
In Commercial Distribution

  • 00630414019772 ()
11219529

  • Haematological cell analyser IVD

Gas Sampling Elbow with Cap - 00636207315335

Gas Sampling Elbow with Cap
Global Life Sciences Solutions USA LLC
VMPELBO
In Commercial Distribution

  • 30636207315336 ()
  • 00636207315335 ()

  • 15 mm - 22 mm filter/elbow connection with gas sampling port and standard luer lock connector
VMPELBO

  • Straight/elbow breathing circuit connector, single-use

Mayo Instrument Tray with Stand - 04946329070569

Mayo Instrument Tray with Stand (Adjustable Height)
MIZUHO CORPORATION
08-333-00
In Commercial Distribution

  • 04946329070569 ()

  • Length: 1370 Millimeter
08-333-00

  • Instrument tray, reusable

V-707 with Power Pack(100-120V) - 04942962613057

No Description
ATOM MEDICAL CORPORATION
61305
Not in Commercial Distribution

  • 04942962613057 ()

  • Depth: 44 Centimeter
  • Width: 95 Centimeter
61305

  • Transport infant incubator

Skull Pin with big tip - 04251269201028

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269201028 ()
114096

  • MRI system coil, radio-frequency

Bend-Cut Saw with one blade - D2483040421

Bend-Cut Saw with one blade
HAGER WORLDWIDE, INC.
304042
In Commercial Distribution

  • D2483040421 ()


  • Dental wax carver

SOMNOscreen HD EEG32 with Camera - 04250413410699

No Description
SOMNOmedics AG
NGDV741U
In Commercial Distribution

  • 04250413410699 ()


  • Polysomnograph

BOW WITH FINGER TRAP SET - 00842430112874

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3334
In Commercial Distribution

  • 00842430112874 ()
3334

  • Surgical traction tensioner connector

INSITE SUPINE TOP WITH PAD - 00842430111617

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
6844-169
In Commercial Distribution

  • 00842430111617 ()
6844-169

  • Universal operating table top

Dingmann mouth gag, frame with - 04250381885871

2 cheek retractors, 2 teeth hooks and 2 thread guides
Spiggle & Theis Medizintechnik GmbH
40-327-00
In Commercial Distribution

  • 04250381885871 ()
40-327-00

  • Mouth gag, adjustable, reusable

Suction tube with interruptor, tip - 04250381858851

closed, two side openings 3.0 mm, 28 cm
Spiggle & Theis Medizintechnik GmbH
50-349-30
In Commercial Distribution

  • 04250381858851 ()
50-349-30

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable

Jackson laryngoscope with handle and - 04250381858608

light carrier, inside satin finished size 3, 180 mm long
Spiggle & Theis Medizintechnik GmbH
50-233-03
In Commercial Distribution

  • 04250381858608 ()
50-233-03

  • Rigid intubation laryngoscope, reusable

Mallet with aluminium handle, metal - 04250381853337

head, nylon facings 24.5 cm
Spiggle & Theis Medizintechnik GmbH
20-403-23
In Commercial Distribution

  • 04250381853337 ()
20-403-23

  • Surgical mallet

Cottle osteotome with single guard - 04250381852279

straight, with crossbar, 5 mm 18.5 cm
Spiggle & Theis Medizintechnik GmbH
20-431-05
In Commercial Distribution

  • 04250381852279 ()
20-431-05

  • Plastic surgery osteotome

Cottle chisel, flat, with crossbar - 04250381852217

12 mm, 18.5 cm
Spiggle & Theis Medizintechnik GmbH
20-406-12
In Commercial Distribution

  • 04250381852217 ()
20-406-12

  • Nasal chisel

Zöllner suction tip with stylet - 04250381847206

0,7 mm, 4 cm
Spiggle & Theis Medizintechnik GmbH
10-310-07
In Commercial Distribution

  • 04250381847206 ()
10-310-07

  • Surgical irrigation/aspiration cannula, non-illuminating, reusable

Gastrostomy Tube with ENFit connector - 10888277411081

Gastrostomy Tube with ENFit connector, 24FR
MEDLINE INDUSTRIES, INC.
ENFIT70324
In Commercial Distribution

  • 20888277411088 ()
  • 10888277411081 ()
70-0064-224

  • Gastrostomy tube

Gastrostomy Tube with ENFit connector - 10888277411074

Gastrostomy Tube with ENFit connector 22FR
MEDLINE INDUSTRIES, INC.
ENFIT70322
In Commercial Distribution

  • 20888277411071 ()
  • 10888277411074 ()
70-0064-222

  • Gastrostomy tube

Gastrostomy Tube with ENFit connector - 10888277411067

Gastrostomy Tube with ENFit connector, 20FR
MEDLINE INDUSTRIES, INC.
ENFIT70320
In Commercial Distribution

  • 20888277411064 ()
  • 10888277411067 ()
70-0064-220

  • Gastrostomy tube

Gastrostomy Tube with ENFit connector - 10888277411050

Gastrostomy Tube with ENFit connector, 18FR
MEDLINE INDUSTRIES, INC.
ENFIT70318
In Commercial Distribution

  • 20888277411057 ()
  • 10888277411050 ()
70-0064-218

  • Gastrostomy tube

Gastrostomy Tube with ENFit connector - 10888277411043

Gastrostomy Tube with ENFit connector, 16FR
MEDLINE INDUSTRIES, INC.
ENFIT70316
In Commercial Distribution

  • 20888277411040 ()
  • 10888277411043 ()
70-0064-116

  • Gastrostomy tube

Gastrostomy Tube with ENFit connector - 10888277411036

Gastrostomy Tube with ENFit connector, 14FR
MEDLINE INDUSTRIES, INC.
ENFIT70314
In Commercial Distribution

  • 20888277411033 ()
  • 10888277411036 ()
70-0064-114

  • Gastrostomy tube

Lower face cuff with link - 04250387100541

Lower face cuff with link
Hilotherm GmbH
Cuff - single patient use
In Commercial Distribution

  • 04250387100541 ()
15000012

  • Circulating-fluid localized thermal therapy system pack, single-use

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 Awl with blunt tip - 04260148896651

No Description
Paradigm Spine GmbH
HAT50252
In Commercial Distribution

  • 04260148896651 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Trocar cannulated with K-wire - 04260148896637

No Description
Paradigm Spine GmbH
HAT5010K
In Commercial Distribution

  • 04260148896637 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Cannulated Handle with Ratchet - 04260148896521

No Description
Paradigm Spine GmbH
HAT40122
In Commercial Distribution

  • 04260148896521 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Awl with blunt tip - 04260148896248

No Description
Paradigm Spine GmbH
HAT50250
In Commercial Distribution

  • 04260148896248 ()


  • 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

DSS™ Trocar with spacer - 04260148893339

No Description
Paradigm Spine GmbH
DAT50101
In Commercial Distribution

  • 04260148893339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DSS, Measuring adapter with k-wire - 04260148893117

No Description
Paradigm Spine GmbH
DAT30425
In Commercial Distribution

  • 04260148893117 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

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

SKORE Thin Condoms with Flavors - 08906007135436

The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry 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 Strawberry 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 Strawberry
In Commercial Distribution

  • 08906007135443 ()
  • 08906007135436 ()
  • 08906007135450 ()
  • 08906007135467 ()


  • Basic male condom, Hevea-latex

Brainlab Interface Rotating, with Marking - 04251269204715

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269204715 ()
113382

  • MRI system coil, radio-frequency

IDS WITH POWER SUPPLY UNIT - 04049098007610

No Description
DRAEGER MEDICAL SYSTEMS, INC.
7265130
In Commercial Distribution

  • 04049098007610 ()


  • Patient monitoring system module, interfacing

Vent Set COAX with Holder - 04048675026648

No Description
Drägerwerk AG & Co. KGaA
MP00316
Not in Commercial Distribution

  • 04048675026648 ()
  • 04048675422303 ()


  • Ventilator breathing circuit, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK2030NC0

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK2030NC2 ()
  • H862TIVK2030NC1 ()
  • H862TIVK2030NC0 ()

  • Length: 94 Centimeter
TIVK2030

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK20300

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK20302 ()
  • H862TIVK20301 ()
  • H862TIVK20300 ()

  • Length: 94 Centimeter
TIVK2030

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH40NC0

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH40NC2 ()
  • H862TIVH40NC1 ()
  • H862TIVH40NC0 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH400

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH402 ()
  • H862TIVH401 ()
  • H862TIVH400 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH30NC0

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH30NC2 ()
  • H862TIVH30NC1 ()
  • H862TIVH30NC0 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH300

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH302 ()
  • H862TIVH301 ()
  • H862TIVH300 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH20NC0

Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH20NC2 ()
  • H862TIVH20NC1 ()
  • H862TIVH20NC0 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVCNC0

Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVCNC2 ()
  • H862TIVCNC1 ()
  • H862TIVCNC0 ()

  • Length: 94 Centimeter
TIVC

  • Valvulotome, percutaneous
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