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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 - 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

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

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

RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc - 00191083045085

No Description
Rti Surgical, Inc.
ZR0301
In Commercial Distribution

001505Z

  • Bone matrix implant, human-derived

Helsinki Hydrodissector (Curved) 27g x 7/8” (0.4 x 22mm) - 08717872012797

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
52.5155
In Commercial Distribution

  • 18717872012794 ()
  • 08717872012797 ()
52.5155

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Sauter Hydrodissector (Curved) 27g x 7/8” (0.4 x 22mm) - 08717872012742

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
52.5099
In Commercial Distribution

  • 18717872012749 ()
  • 08717872012742 ()
52.5099

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Anaesthetic Cannula, Retrobulbar – Atkinson 25g x 1.5 ” (0.5 x 38mm) - 08717872012605

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
52.1637
In Commercial Distribution

  • 18717872012602 ()
  • 08717872012605 ()
52.1637

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Formed Irrigating Cystotome 25g x 5/8” (0.5 x 16mm) - 08717872012551

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
52.1610
In Commercial Distribution

  • 18717872012558 ()
  • 08717872012551 ()
52.1610

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Bedside Bi-Fold Foam Floor Mat, 36" x 66" x 2" - 00840117326606

No Description
Dynarex Corporation
13021
In Commercial Distribution

  • 00840117326606 ()


  • Anti-fatigue floor mat

Bedside Bi-Fold Foam Floor Mat, 24" x 66" x 2" - 00840117326590

No Description
Dynarex Corporation
13020
In Commercial Distribution

  • 00840117326590 ()


  • Anti-fatigue floor mat

DynaClip Bone Fixation System, Quattro, 22mm x 20mm x 20mm - M9703000112220200

No Description
Medshape, Inc.
3000-11-222020
In Commercial Distribution

  • M9703000112220200 ()


  • Orthopaedic bone staple, non-adjustable

DynaClip Bone Fixation System, Quattro, 22mm x 16mm x 16mm - M9703000112216160

No Description
Medshape, Inc.
3000-11-221616
In Commercial Distribution

  • M9703000112216160 ()


  • Orthopaedic bone staple, non-adjustable

DynaClip Bone Fixation System, Quattro, 18mm x 16mm x 16mm - M9703000111816160

No Description
Medshape, Inc.
3000-11-181616
In Commercial Distribution

  • M9703000111816160 ()


  • Orthopaedic bone staple, non-adjustable

Reprocessed Oscillating Saw Blade Coated, 13 x 70 x 1.19mm - B39050713531

No Description
SURETEK MEDICAL
5071-353
In Commercial Distribution

  • B39050713531 ()


  • Surgical power tool system handpiece, sawing, line-powered

Reprocessed Oscillating Saw Blade Coated, 19.5 x 95 x 1.27mm - B39050712671

No Description
SURETEK MEDICAL
5071-267
In Commercial Distribution

  • B39050712671 ()


  • Surgical power tool system handpiece, sawing, line-powered

Reprocessed Large Bone Knee Blade, 25 x 90 x 1.27mm - B39050711611

No Description
SURETEK MEDICAL
5071-161
In Commercial Distribution

  • B39050711611 ()


  • Surgical power tool system handpiece, sawing, line-powered

Reprocessed Large Bone Knee Blade,19.0 x 105 x 1.27mm - B39050711291

No Description
SURETEK MEDICAL
5071-129
In Commercial Distribution

  • B39050711291 ()


  • Surgical power tool system handpiece, sawing, line-powered

Reprocessed Large Bone Knee Blade, 19.5 x 95 x 1.27mm - B39050711231

No Description
SURETEK MEDICAL
5071-123
In Commercial Distribution

  • B39050711231 ()


  • Surgical power tool system handpiece, sawing, line-powered

Reprocessed Micro Sagittal Blade, Fine, 9.5 x 25.5 x 0.4mm - B39050231831

No Description
SURETEK MEDICAL
5023-183
In Commercial Distribution

  • B39050231831 ()


  • Surgical power tool system handpiece, sawing, line-powered

Reprocessed Micro Oscillating Blade, Crescentic, 18 x 32 x 0.4mm - B39050231721

No Description
SURETEK MEDICAL
5023-172
In Commercial Distribution

  • B39050231721 ()


  • Surgical power tool system handpiece, sawing, line-powered
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