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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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Osbone Dental - ECURH05M0250

Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and sinus floor elevation (subantral augmentation) - Filling of alveolar defects following tooth extraction for alveolar ridge preservation - Filling of extraction defects to create an implant bed - Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects - Support function for a membrane in controlled tissue regeneration (CTR) - Defects after surgical removal of retained teeth or corrective osteotomies - Other multi-walled bone defects of the alveolar processes
curasan AG
250-1000µm
In Commercial Distribution

  • ECURH05M0250 ()
  • ECURH05M02505 ()

  • Total Volume: 0.5 Centiliter
5 x 0.5 cc

  • Synthetic bone graft

CERASORB® Ortho Foam - ECURCOM2550

Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® ORTHO Foam 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. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x50x4 mm
In Commercial Distribution

  • ECURCOM2550 ()
1 x 5.0 cc

  • Bone matrix implant, composite

CERASORB® Ortho Foam - ECURCOM2525

Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® ORTHO Foam 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. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x25x2 mm
In Commercial Distribution

  • ECURCOM2525 ()
1 x 2.5 cc

  • Bone matrix implant, composite

CERASORB® Ortho Foam - ECURCOM2512

Device Name: CERASORB® Ortho Foam Mofidication: Mouldable Foam Indication for Use: Cerasorb® ORTHO Foam 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. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x12x4 mm
In Commercial Distribution

  • ECURCOM2512 ()
1 x 1.2 cc

  • Bone matrix implant, composite

CERASORB® Ortho Foam - ECURCOF6565

Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Cerasorb® ORTHO Foam 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. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
65x65x6 mm
In Commercial Distribution

  • ECURCOF6565 ()
1 x 25.0 cc

  • Bone matrix implant, composite

CERASORB® Ortho Foam - ECURCOF2550

Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Cerasorb® ORTHO Foam 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. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x50x4 mm
In Commercial Distribution

  • ECURCOF2550 ()
1 x 0.5 cc

  • Bone matrix implant, composite

CERASORB® Ortho Foam - ECURCOF25100

Device Name: CERASORB® Ortho Foam Mofidication: Flexible Foam Stripe Indication for Use: Cerasorb® ORTHO Foam 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. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x100x4 mm
In Commercial Distribution

  • ECURCOF25100 ()
1 x 10.0 cc

  • Bone matrix implant, composite

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 - 00810124531218

Nonsterile Cotton Rolls 1lb
Avaline Medical NJ Limited Liability Company
CR 1LB x 1
In Commercial Distribution

CR 1LB x 1

  • Cotton wool roll

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

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

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

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

RECTANGLE BOWL (2.8"L x 2.4"W x .75"H) - D9281080170

No Description
W.H. Holden, Inc.
10-8017
In Commercial Distribution

  • D9281080170 ()


  • General-purpose bowl, reusable

CASSETTE - 8" X 14.5" X 1.25" S/S W/ INSERTS - D9281073240

No Description
W.H. Holden, Inc.
10-7324
In Commercial Distribution

  • D9281073240 ()


  • Instrument tray, reusable

MaxFuse,VBR, 12 (D) x 14 (W) x 38 (H) - 00846468056384

No Description
Pioneer Surgical Technology, Inc.
62-1517-64
Not in Commercial Distribution

  • 00846468056384 ()
62-1517-64

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 37 (H) - 00846468056377

12 (D) x 14 (W) x 37 (H)
Pioneer Surgical Technology, Inc.
62-1517-63
Not in Commercial Distribution

  • 00846468056377 ()
62-1517-63

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 37 (H) - 00846468056360

12 (D) x 14 (W) x 37 (H)
Pioneer Surgical Technology, Inc.
62-1517-62
Not in Commercial Distribution

  • 00846468056360 ()
62-1517-62

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 36 (H) - 00846468056353

No Description
Pioneer Surgical Technology, Inc.
62-1517-61
Not in Commercial Distribution

  • 00846468056353 ()


  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 35 (H) - 00846468056339

12 (D) x 14 (W) x 35 (H)
Pioneer Surgical Technology, Inc.
62-1517-59
Not in Commercial Distribution

  • 00846468056339 ()
62-1517-59

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 34 (H) - 00846468056315

12 (D) x 14 (W) x 34 (H)
Pioneer Surgical Technology, Inc.
62-1517-57
Not in Commercial Distribution

  • 00846468056315 ()
62-1517-57

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 33 (H) - 00846468056292

12 (D) x 14 (W) x 33 (H)
Pioneer Surgical Technology, Inc.
62-1517-55
Not in Commercial Distribution

  • 00846468056292 ()
62-1517-55

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 32 (H) - 00846468056278

VBR, 12 (D) x 14 (W) x 32 (H)
Pioneer Surgical Technology, Inc.
62-1517-53
Not in Commercial Distribution

  • 00846468056278 ()
62-1517-53

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 31 (H) - 00846468056254

12 (D) x 14 (W) x 31 (H)
Pioneer Surgical Technology, Inc.
62-1517-51
Not in Commercial Distribution

  • 00846468056254 ()
62-1517-51

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 30 (H) - 00846468056230

12 (D) x 14 (W) x 30 (H)
Pioneer Surgical Technology, Inc.
62-1517-49
Not in Commercial Distribution

  • 00846468056230 ()
62-1517-49

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 29 (H) - 00846468056216

VBR, 12 (D) x 14 (W) x 29 (H)
Pioneer Surgical Technology, Inc.
62-1517-47
Not in Commercial Distribution

  • 00846468056216 ()
62-1517-47

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 28 (H) - 00846468056193

VBR, 12 (D) x 14 (W) x 28 (H)
Pioneer Surgical Technology, Inc.
62-1517-45
Not in Commercial Distribution

  • 00846468056193 ()
62-1517-45

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 23 (H) - 00846468056094

VBR, 12 (D) x 14 (W) x 23 (H)
Pioneer Surgical Technology, Inc.
62-1517-35
Not in Commercial Distribution

  • 00846468056094 ()
62-1517-35

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 22 (H) - 00846468056070

12 (D) x 14 (W) x 22 (H)
Pioneer Surgical Technology, Inc.
62-1517-33
Not in Commercial Distribution

  • 00846468056070 ()
62-1517-33

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 22 (H) - 00846468056063

12 (D) x 14 (W) x 22 (H)
Pioneer Surgical Technology, Inc.
62-1517-32
Not in Commercial Distribution

  • 00846468056063 ()
62-1517-32

  • Vertebral body prosthesis
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