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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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JULIET ® Ti PO - 07640151093884

JUT-PX 24 08-S
SpineArt SA
JUT-PX 24 08-S
Not in Commercial Distribution

  • 07640151109714 ()
  • 07640151093884 ()

  • Height: 08 Millimeter
  • Width: 10.5 Millimeter
  • Length: 24 Millimeter
  • Angle: 12 degree
JUT-PX 24 08-S

  • Metallic spinal interbody fusion cage

X-MESH - 10705034160580

X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 65 - 90mm, 0/24 DEGREES
Medos International Sàrl
188912565
Not in Commercial Distribution

  • 10705034160580 ()
188912565

  • Metallic spinal interbody fusion cage

X-MESH - 10705034160573

X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 51 - 71mm, 0/24 DEGREES
Medos International Sàrl
188912551
Not in Commercial Distribution

  • 10705034160573 ()
188912551

  • Metallic spinal interbody fusion cage

X-MESH - 10705034160566

X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 40 - 56mm, 0/24 DEGREES
Medos International Sàrl
188912540
Not in Commercial Distribution

  • 10705034160566 ()
188912540

  • Metallic spinal interbody fusion cage

Epicel (cultured epidermal autografts) - W41020AU201S1969

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

Surgiderm - 24 XP - 05060457760242

No Description
LAMBSMEAD LTD
828457SM
In Commercial Distribution

  • 05060457760242 ()


  • Dermal tissue reconstructive material, animal-derived

CHOLE KIT 24 - 30607915135592

Kit Contains: C0R95, 12x100 Kii BLUNT TIP SM CONE 6/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK320
In Commercial Distribution

  • 30607915135592 ()


  • Laparoscopic irrigation/aspiration cannula
  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic

ATRAMAT - 07500142008931

ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 0 EP 3,5, 75 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE POLIPROPILENO AZUL USP 0, 75 CM AGUJA CE-24 REVERSO CORTANTE 24 MM 3/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
POLIPROPILENO
In Commercial Distribution

  • 07500142108938 ()
  • 07500142008931 ()

  • USP 0
  • Length: 24 Millimeter
  • 3/8 CIRCLE
  • SUTURE BLUE
  • ATRAMAT POLYPROPYLENE
CE2461-75

  • Polyolefin/fluoropolymer suture, monofilament

ATRAMAT - 07500142002847

ATRAMAT SILK SURGICAL SUTURE BLACK USP 0 EP 3,5, 75 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE SEDA NEGRA USP 0, 75 CM AGUJA CE-24 REVERSO CORTANTE 24 MM 3/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
SEDA
In Commercial Distribution

  • 07500142102844 ()
  • 07500142002847 ()

  • Length: 24 Millimeter
  • 3/8 CIRCLE
  • SUTURE BLACK
  • ATRAMAT SILK
  • USP 0
CE2431

  • Silk suture

ATRAMAT - 07500142000904

ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 75 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE NYLON NEGRO USP 0, 75 CM AGUJA CE-24 REVERSO CORTANTE 24 MM 3/8 CIRCULO
Internacional Farmacéutica, S.A. de C.V.
NYLON
In Commercial Distribution

  • 07500142100901 ()
  • 07500142000904 ()

  • Length: 24 Millimeter
  • 3/8 CIRCLE
  • SUTURE BLACK
  • ATRAMAT NYLON
  • USP 0
CE2441-75N

  • Nylon suture, non-bioabsorbable, monofilament
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