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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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Matriform SI-Strip - ECUR449100

Device Name: Matriform Strip Indication for Use: Matriform® Si Strip is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process
curasan AG
100x25x4mm
In Commercial Distribution

  • ECUR449100 ()
1 x 10 cc

  • Bone matrix implant, composite

Matriform SI-Strip - ECUR449050

Device Name: Matriform SI-Strip Indication for Use: Matriform® Si Strip is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process
curasan AG
50x25x4 mm
In Commercial Distribution

  • ECUR449050 ()
1 x 5 cc

  • Bone matrix implant, composite

Matriform Strip - ECUR429100

Device Name: Matriform Strip Mofidication: Flexible Foam Indication for Use: Matriform Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Strip resorbs and is replaced with bone during healing process.
curasan AG
25x100x4mm
In Commercial Distribution

  • ECUR429100 ()
1 x 10 cc

  • Bone matrix implant, composite

Matriform Strip - ECUR429050

Device Name: Matriform Strip Mofidication: Flexible Foam Indication for Use: Matriform Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Strip resorbs and is replaced with bone during healing process.
curasan AG
25x50x4 mm
In Commercial Distribution

  • ECUR429050 ()
1 x 5 cc

  • Bone matrix implant, composite

Matriform Extra Large - ECUR409100

Device Name: Matriform Extra Large Mofidication: Mouldable Foam Indication for Use: Matriform Extra Large is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Extra Large resorbs and is replaced with bone during healing process.
curasan AG
25x100x4 mm
In Commercial Distribution

  • ECUR409100 ()
1 x 10 cc

  • Bone matrix implant, composite

Matriform Large - ECUR409050

Device Name: Matriform Large Mofidication: Mouldable Foam Indication for Use: Matriform Large is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Large resorbs and is replaced with bone during healing process.
curasan AG
25x50x4 mm
In Commercial Distribution

  • ECUR409050 ()
1 x 5 cc

  • Bone matrix implant, composite

Matriform Medium - ECUR409025

Device Name: Matriform Medium Mofidication: Mouldable Foam Indication for Use: Matriform Medium is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Medium resorbs and is replaced with bone during healing process.
curasan AG
25x25x4 mm
In Commercial Distribution

  • ECUR409025 ()
1 x 2.5 cc

  • Bone matrix implant, composite

Matriform Smal - ECUR409012

Device Name: Matriform Smal Mofidication: Mouldable Foam Indication for Use: Matriform Smal is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Smal resorbs and is replaced with bone during healing process.
curasan AG
25x12x4 mm
In Commercial Distribution

  • ECUR409012 ()
1 x 1.2 cc

  • Bone matrix implant, composite

Avaline Medical NJ LLC - 00810077212264

Combine Abdominal Pads 8x10 10 plus Tape
Avaline Medical NJ Limited Liability Company
5810 x 10 +vp
In Commercial Distribution

  • 00810077212455 ()
  • 00810077212264 ()
5810 x 10 +vp

  • Non-woven gauze pad

Avaline Medical NJ LLC - 00810077210031

Washable Underpads 36"x72" x2
Avaline Medical NJ Limited Liability Company
ZRUP3672R X 2 +IG
In Commercial Distribution

  • 00810077212509 ()
  • 00810077210031 ()
ZRUP3672R X 2 +IG

  • Absorbent underpad, non-antimicrobial, reusable

AltaTrack - 00884838099340

Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
Philips Medical Systems Nederland B.V.
AltaTrack equipment
Not in Commercial Distribution

  • 00884838099340 ()
4322 070 2535 X

  • Diagnostic x-ray digital imaging system workstation application software

TCMzone HuoTuo - 00860014142451

Disposable acupuncture needle, 0.25mm × 40mm (#32), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
TIK-0.25mm x 40mm
In Commercial Distribution

  • 00860014142499 ()
  • 00860014142451 ()
TIK-0.25mm x 40mm (#32)

  • Acupuncture needle, single-use

TCMzone HuoTuo - 00860014142444

Disposable acupuncture needle, 0.22mm × 40mm (#34), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
TIK-0.22mm x 40mm
In Commercial Distribution

  • 00860014142482 ()
  • 00860014142444 ()
TIK-0.22mm x 40mm (#34)

  • Acupuncture needle, single-use

TCMzone HuoTuo - 00860014142437

Disposable acupuncture needle, 0.20mm × 40mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
T1K-0.20mm x 40mm
In Commercial Distribution

  • 00860014142475 ()
  • 00860014142437 ()
T1K-0.20mm x 40mm (#36)

  • Acupuncture needle, single-use

TCMzone HuoTuo - 00860014142413

Disposable acupuncture needle, 0.20mm × 30mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
T1K-0.20mm x 30mm
In Commercial Distribution

  • 00860014142475 ()
  • 00860014142413 ()
T1K-0.20mm x 30mm (#36)

  • Acupuncture needle, single-use

TatumSurgical/Screw Implant - 00083208550140

Screw Dental Implant 5.0mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/5.0 x 14
In Commercial Distribution

  • 00083208550140 ()

  • Outer Diameter: 5 Millimeter
  • Screw 5.0mm Diameter x 14mm Length
  • Length: 14 Millimeter
IS 5.0 x 14mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208550119

Screw Dental Implant 5.0mm in diameter and 11mm in length
Suncoast Dental, Inc
Screw/5.0 x 11
In Commercial Distribution

  • 00083208550119 ()

  • Outer Diameter: 5 Millimeter
  • Screw 5.0mm Diameter x 11mm Length
  • Length: 11 Millimeter
IS 5.0 x 11mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208545207

Screw Dental Implant 4.5 in Diameter and 20mm in Length
Suncoast Dental, Inc
Screw/4.5 x 20
In Commercial Distribution

  • 00083208545207 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 20 Millimeter
  • Screw 4.5 mm Diameter x 20mm Length
IS 4.5 x 20mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208545177

Screw Dental Implant 4.5mm in diameter and 17mm in length
Suncoast Dental, Inc
Screw/4.5 x 17
In Commercial Distribution

  • 00083208545177 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 17 Millimeter
  • Screw 4.5mm Diameter x 17mm Length
IS 4.5 x 17mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208545146

Screw Dental Implant 4.5mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/4.5 x 14
In Commercial Distribution

  • 00083208545146 ()

  • Length: 14 Millimeter
  • Screw 4.5mm Diameter x 14mm Length
  • Outer Diameter: 4.5 Millimeter
IS 4.5 x 11mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208545115

Screw Dental Implant 4.5mm in diameter and 11mm in length
Suncoast Dental, Inc
Screw/4.5 x 11
In Commercial Distribution

  • 00083208545115 ()

  • Length: 11 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Screw 4.5mm Diameter x 11mm Length
IS 4.5 x 11mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208540202

Screw Dental Implant 4.0mm in diameter and 20mm in length
Suncoast Dental, Inc
Screw/4.0 x 20
In Commercial Distribution

  • 00083208540202 ()

  • Screw 4.0mm Diameter x 20mm Length
  • Outer Diameter: 4 Millimeter
  • Length: 20 Millimeter
IS 4.0 x 20mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208540172

Screw Dental Implant 4.0mm in diameter and 17mm in length
Suncoast Dental, Inc
Screw/4.0 x 17
In Commercial Distribution

  • 00083208540172 ()

  • Screw 4.0mm Diameter x 17mm Length
  • Length: 17 Millimeter
  • Outer Diameter: 4 Millimeter
IS 4.0 x 17mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208540141

Screw Dental Implant 4.0mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/4.0 x 14
In Commercial Distribution

  • 00083208540141 ()

  • Screw 4.0mm Diameter x 14mm Length
  • Outer Diameter: 4 Millimeter
  • Length: 14 Millimeter
IS 4.0 x 14mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208540110

Screw Dental Implant 4.0mm in diameter and 11mm in length
Suncoast Dental, Inc
Screw/4.0 x 11
In Commercial Distribution

  • 00083208540110 ()

  • Screw 4.0mm Diameter x 11mm Length
  • Length: 11 Millimeter
  • Outer Diameter: 4 Millimeter
IS 4.0 x 11mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208535208

Screw Dental Implant 3.5mm in diameter and 20mm in length
Suncoast Dental, Inc
Screw/3.5 x 20
In Commercial Distribution

  • 00083208535208 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Screw 3.5mm Diameter x 20mm length
IS 3.5 x 20mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208535178

Screw Dental Implant 3.5mm in diameter and 17mm in length
Suncoast Dental, Inc
Screw/3.5 x 17
In Commercial Distribution

  • 00083208535178 ()

  • Length: 17 Millimeter
  • Screw 3.5mm Diameter x 17mm length
  • Outer Diameter: 3.5 Millimeter
IS 3.5 x 17mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208535147

Screw Dental Implant 3.5mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/3.5 x 14
In Commercial Distribution

  • 00083208535147 ()

  • Screw 3.5mm Diameter x 14mm length
  • Outer Diameter: 3.5 Millimeter
  • Length: 14 Millimeter
IS 3.5 x 14mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208517808

Screw Dental Implant 8.0mm in diameter and 17mm in length
Suncoast Dental, Inc
Screw/8.0 x 17
In Commercial Distribution

  • 00083208517808 ()

  • Length: 17 Millimeter
  • Outer Diameter: 8 Millimeter
  • Screw 8.0mm Diameter x 17mm Length
IS 8.0 x 17mm

  • Screw endosteal dental implant, two-piece

Tatum Surgical IP Press Fit Abutment - 00083208506215

0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 6.0mm Cuff Height
Suncoast Dental, Inc
IP-PN-5.0 x 6 (CB) Abutment
In Commercial Distribution

  • 00083208506215 ()

  • Outer Diameter: 5.0 Millimeter
  • Height: 6 Millimeter
  • Angle: 0 degree
IP-PN-5.0 x 6 (CB)

  • Screw endosteal dental implant, two-piece

Tatum Surgical IP Press Fit Abutment - 00083208505218

0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 5.0mm Cuff Height
Suncoast Dental, Inc
IP-PN-5.0 x 5 (CB) Abutment
In Commercial Distribution

  • 00083208505218 ()

  • Outer Diameter: 5.0 Millimeter
  • Height: 5 Millimeter
  • Angle: 0 degree
IP-PN-5.0 x 5 (CB)

  • Screw endosteal dental implant, two-piece

Tatum Surgical IP Press Fit Abutment - 00083208504211

0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 4.0mm Cuff Height
Suncoast Dental, Inc
IP-PN-5.0 x 4 (CB) Abutment
In Commercial Distribution

  • 00083208504211 ()

  • Outer Diameter: 5.0 Millimeter
  • Height: 4 Millimeter
  • Angle: 0 degree
IP-PN-5.0 x 4 (CB)

  • Screw endosteal dental implant, two-piece

Tatum Surgical IP Press Fit Abutment - 00083208503214

0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 3.0mm Cuff Height
Suncoast Dental, Inc
IP-PN-5.0 x 3 (CB) Abutment
In Commercial Distribution

  • 00083208503214 ()

  • Outer Diameter: 5.0 Millimeter
  • Height: 3 Millimeter
  • Angle: 0 degree
IP-PN-5.0 x 3 (CB)

  • Screw endosteal dental implant, two-piece

Tatum Surgical IP Press Fit Abutment - 00083208502217

0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height
Suncoast Dental, Inc
IP-PN-5.0 x 2 (CB) Abutment
In Commercial Distribution

  • 00083208502217 ()

  • Outer Diameter: 5.0 Millimeter
  • Height: 2 Millimeter
  • Angle: 0 degree
IP-PN-5.0 x 2 (CB)

  • Screw endosteal dental implant, two-piece

Tatum Surgical/IP 5.0 x 11.0mm - 00083208501197

Press Fit Implant 5.0 x 11.0mm x 3mm Well Morse Taper
Suncoast Dental, Inc
IP 5.0 x 11.0mm
In Commercial Distribution

  • 00083208501197 ()

  • Press Fit Implant 5.0 x 11.0mm x 3mm Well Morse Taper
  • Outer Diameter: 5 Millimeter
  • Height: 11 Millimeter
IP 5.0 x 11.0mm

  • Screw endosteal dental implant, two-piece

Tatum Surgical/IP 5.0 x 8.0mm - 00083208500893

Press Fit Implant 5.0 x 8.0mm x 3mm Well Morse Taper
Suncoast Dental, Inc
IP 5.0 x 8.0mm
In Commercial Distribution

  • 00083208500893 ()

  • Press Fit Implant 5.0 x 8.0mm x 3mm Well Morse Taper
  • Height: 8 Millimeter
  • Outer Diameter: 5 Millimeter
IP 5.0 x 8.0mm

  • Screw endosteal dental implant, two-piece

Tatum Surgical/IP 5.0 x 6.0mm - 00083208500695

Press Fit Implant 5.0 x 6.0mm x 3mm Well Morse Taper
Suncoast Dental, Inc
IP 5.0 x 6.0mm
In Commercial Distribution

  • 00083208500695 ()

  • Outer Diameter: 5 Millimeter
  • Height: 6 Millimeter
  • Press Fit Implant 5.0 x 6.0mm x 3mm Well Morse Taper
IP 5.0 x 6.0mm

  • Screw endosteal dental implant, two-piece

Tatum Surgical/ IP-BP 5.0mm Long Ball Post Attachment - 00083208500329

IP-BP 5.0mm Long Ball Post Attachment
Suncoast Dental, Inc
IP-BP-5.0xSB-L
In Commercial Distribution

  • 00083208500329 ()

  • Outer Diameter: 5 Millimeter
  • IP- BP 5.0mm Long Ball Post Attachment
IP-BP 5.0 x SB-L

  • Dental implant suprastructure, permanent, preformed

Tatum Surgical/ IP-BP 5.0mm Medium Ball Post Attachment - 00083208500220

IP-BP 5.0mm Medium Ball Post Attachment
Suncoast Dental, Inc
IP-BP-5.0xSB-M
In Commercial Distribution

  • 00083208500220 ()

  • Outer Diameter: 5 Millimeter
  • IP- BP 5.0mm Medium Ball Post Attachment
IP-BP 5.0 x SB-M

  • Dental implant suprastructure, permanent, preformed

Tatum Surgical/ IP-BP 5.0mm Short Ball Post Attachment - 00083208500121

IP-BP 5.0mm Short Ball Post Attachment
Suncoast Dental, Inc
IP-BP-5.0xSB-S
In Commercial Distribution

  • 00083208500121 ()

  • IP- BP 5.0mm Short Ball Post Attachment
  • Outer Diameter: 5 Millimeter
IP-BP 5.0 x SB-S

  • Dental implant suprastructure, permanent, preformed
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