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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No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/3.5cm
In Commercial Distribution

  • 00827002356474 ()
70-0042-614

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/3.0cm
In Commercial Distribution

  • 00827002356467 ()
70-0042-514

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/2.5cm
In Commercial Distribution

  • 00827002356450 ()
70-0042-414

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/2.0cm
In Commercial Distribution

  • 00827002356443 ()
70-0042-314

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/1.5cm
In Commercial Distribution

  • 00827002356436 ()
70-0042-214

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/1.0cm
In Commercial Distribution

  • 00827002356429 ()
70-0042-114

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 14 FR/0.8cm
In Commercial Distribution

  • 00827002356412 ()
70-0042-014

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/4.0cm
In Commercial Distribution

  • 00827002356405 ()
70-0042-712

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/3.5cm
In Commercial Distribution

  • 00827002356399 ()
70-0042-612

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/3.0cm
In Commercial Distribution

  • 00827002356382 ()
70-0042-512

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/2.5cm
In Commercial Distribution

  • 00827002356375 ()
70-0042-412

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/2.0cm
In Commercial Distribution

  • 00827002356368 ()
70-0042-312

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/1.0cm
In Commercial Distribution

  • 00827002356221 ()
70-0042-112

  • Gastrostomy tube
No Description
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/0.8cm
In Commercial Distribution

  • 00827002356214 ()
70-0042-012

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 24 FR Ref. Number: SBRD-24
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 24 FR
In Commercial Distribution

  • 00827002356207 ()
70-0041-224

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 22 FR Ref. Number: SBRD-22
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 22 FR
In Commercial Distribution

  • 00827002356191 ()
70-0041-222

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 20 FR Ref. Number: SBRD-20
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 20 FR
In Commercial Distribution

  • 00827002356184 ()
70-0041-220

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 18 FR Ref. Number: SBRD-18
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 18 FR
In Commercial Distribution

  • 00827002356177 ()
70-0041-118

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 16 FR Ref. Number: SBRD-16
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 16 FR
In Commercial Distribution

  • 00827002356160 ()
70-0041-116

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 14 FR Ref. Number: SBRD-14
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 14 FR
In Commercial Distribution

  • 00827002356153 ()
70-0041-114

  • Gastrostomy tube
Entuit Gastrostomy BR Balloon Retention Feeding Tube, 12 FR Ref. Number: SBRD-12
XERIDIEM MEDICAL DEVICES, INC.
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube - 12 FR
In Commercial Distribution

  • 00827002356146 ()
70-0041-112

  • Gastrostomy tube
The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp
ABBVIE INC.
62912
In Commercial Distribution

  • 08054083004976 ()


  • Gastrostomy tube
The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp
ABBVIE INC.
62910
In Commercial Distribution

  • 08054083004952 ()


  • Gastrostomy tube
The saleable unit (device count) is 1, there are 5 fixation plates in the saleable unit
ABBVIE INC.
62928
In Commercial Distribution

  • 08054083004921 ()


  • Gastrostomy tube
The saleable unit (device count) is 1, there are 5 fixation plates in the saleable unit
ABBVIE INC.
62920
In Commercial Distribution

  • 08054083004877 ()


  • Gastrostomy tube
No Description
CITIEFFE SRL
Dolphix Distractor-compactor, L
In Commercial Distribution

  • 08052990970056 ()
DF300265

  • External orthopaedic fixation system, single-use, sterile
No Description
CITIEFFE SRL
Dolphix cable ties (4 pcs)
In Commercial Distribution

  • 08056711920320 ()
DF900001

  • External orthopaedic fixation system, single-use
Cortical bone screw with hydroxyapatite coating ø6mm L180mm - Thread L35mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated.
CITIEFFE SRL
HA cortical bone screw ø6mm L180-35mm
In Commercial Distribution

  • 08056711920054 ()

  • Outer Diameter: 6 Millimeter
  • Length: 180 Millimeter
ST360178HA

  • External orthopaedic fixation system, single-use
Cortical bone screw with hydroxyapatite coating ø6mm L150mm - Thread L30mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated.
CITIEFFE SRL
HA cortical bone screw ø6mm L150-30mm
In Commercial Distribution

  • 08056711920047 ()

  • Outer Diameter: 6 Millimeter
  • Length: 150 Millimeter
ST360148HA

  • External orthopaedic fixation system, single-use
Cortical bone screw with hydroxyapatite coating ø6mm L200mm - Thread L40mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated.
CITIEFFE SRL
HA cortical bone screw ø6mm L200-40mm
In Commercial Distribution

  • 08056711920061 ()

  • Length: 200 Millimeter
  • Outer Diameter: 6 Millimeter
ST360198HA

  • External orthopaedic fixation system, single-use
CASTROVIEJO CALIPER 75MM
Aesculap AG
OB792R
In Commercial Distribution

  • 04046964090837 ()
OB792R

  • General-purpose calliper, metallic
CALIPER 170MM
Aesculap AG
OB793R
Not in Commercial Distribution

  • 04046964089350 ()
OB793R

  • General-purpose calliper, metallic
VALVE XS TENDINOUS CORDS RULER 355MM
Aesculap AG
FC357R
In Commercial Distribution

  • 04046963954963 ()
FC357R

  • General-purpose calliper, metallic
HOUSE EAR CALIPER WITH ROD MARK
SONTEC INSTRUMENTS, INC.
1463-142
In Commercial Distribution

  • 00192896059023 ()

  • 4.5 Millimeter Tip
  • Length: 6.25 Inch
1463-142

  • General-purpose calliper, metallic
HOUSE EAR CALIPER WITH ROD MARK
SONTEC INSTRUMENTS, INC.
1463-141
In Commercial Distribution

  • 00192896059016 ()

  • Length: 6.25 Inch
  • 4 Millimeter Tip
1463-141

  • General-purpose calliper, metallic
HOUSE EAR CALIPER WITH ROD MARK
SONTEC INSTRUMENTS, INC.
1463-140
In Commercial Distribution

  • 00192896059009 ()

  • Length: 6.25 Inch
  • 3.5 Millimeter Tip
1463-140

  • General-purpose calliper, metallic
MDM Assembly Tool Base Bushing
Exactech, Inc.
SPI-007565
In Commercial Distribution

  • 10885862634061 ()
SPI-007565

  • External orthopaedic fixation system, single-use
MIS ROD CALIPER
HYHTE HOLDINGS, INC.
AZE200000
In Commercial Distribution

  • 00841379165705 ()
AZE200000

  • General-purpose calliper, metallic
TESSIER-TYPE CALIPER 255MM
AESCULAP, INC.
MA004R
In Commercial Distribution

  • 04046964566172 ()
MA004R

  • General-purpose calliper, metallic
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509440
In Commercial Distribution

  • 08714729902690 ()

  • 4.4 cm Length
  • 8.0 mm Diameter
  • 24 F Diameter
M00509440

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509430
In Commercial Distribution

  • 08714729902683 ()

  • 3.4 cm Length
  • 24 F Diameter
  • 8.0 mm Diameter
M00509430

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509420
In Commercial Distribution

  • 08714729902676 ()

  • 2.4 cm Length
  • 24 F Diameter
  • 8.0 mm Diameter
M00509420

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509410
In Commercial Distribution

  • 08714729902669 ()

  • 8.0 mm Diameter
  • 1.7 cm Length
  • 24 F Diameter
M00509410

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509870
In Commercial Distribution

  • 08714729902652 ()

  • 4.4 cm Length
  • 6.0 mm Diameter
  • 18 F Diameter
M00509870

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509860
In Commercial Distribution

  • 08714729902645 ()

  • 6.0 mm Diameter
  • 18 F Diameter
  • 3.4 cm Length
M00509860

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509850
In Commercial Distribution

  • 08714729902638 ()

  • 18 F Diameter
  • 6.0 mm Diameter
  • 2.4 cm Length
M00509850

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509840
In Commercial Distribution

  • 08714729902621 ()

  • 6.0 mm Diameter
  • 18 F Diameter
  • 1.7 cm Length
M00509840

  • Gastrostomy tube
Low Profile Replacement Gastrostomy Tube
BOSTON SCIENTIFIC CORPORATION
M00509830
In Commercial Distribution

  • 08714729902614 ()

  • 6.0 mm Diameter
  • 1.2 cm Length
  • 18 F Diameter
M00509830

  • Gastrostomy tube
K-wire ruler and pin gauge, 6'', measurements in inches and millimeters
AMBLER SURGICAL CORP.
K-wire ruler and pin gauge
In Commercial Distribution

  • 00190660215415 ()
44-678

  • General-purpose calliper, metallic
Trial Stimulator
AXONICS MODULATION TECHNOLOGIES, INC.
1601
In Commercial Distribution

  • 10810005340059 ()
1601

  • Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator
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