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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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TRAY, BMET-11ANL, F/G PN 74075-02M
RANFAC CORP.
11 Gauge x 4"
In Commercial Distribution

  • M9797407502M9 ()
  • M9797407502M0 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
BMET-11ANL

  • Bone marrow biopsy procedure kit
BMET-11A, F/G PN 74075-01M
RANFAC CORP.
11 GAUGE x 4"
In Commercial Distribution

  • M9797407501M9 ()
  • M9797407501M0 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
BMET-11A

  • Bone marrow biopsy procedure kit
Pak12G assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12G
Not in Commercial Distribution

  • 10888234500223 ()
PAK12G

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
No Description
G21 SRL
611-01-140
In Commercial Distribution

  • 08058964729026 ()


  • Orthopaedic cement, antimicrobial
No Description
G21 SRL
610-01-140
In Commercial Distribution

  • 08058964729019 ()


  • Orthopaedic cement, antimicrobial
Contains VT601US(ES,VS×2), 4 of cryotopUSs(Green)and Repro Plate
KITAZATO CORPORATION
VT601US-TOP(G)
In Commercial Distribution

  • 24582231462616 ()
  • 14582231462596 ()


  • IVF medium kit
Surgical Handpiece for 3I
W & H Dentalwerk Bürmoos GmbH
10207564
Not in Commercial Distribution

  • J021102075641 ()


  • Dental surgical power tool motorized handpiece/set, electric
Surgical Handpiece
W & H Dentalwerk Bürmoos GmbH
00001120
Not in Commercial Distribution

  • J021000011201 ()


  • Dental surgical power tool motorized handpiece/set, electric
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system. In bone infection, CERAMENT G can also be inserted as pre-set beads.
Bone Support AB
A0535-06
In Commercial Distribution

  • 07350055430530 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system. In bone infection, CERAMENT G can also be inserted as pre-set beads.
Bone Support AB
A0535-05
In Commercial Distribution

  • 07350055430523 ()

  • Total Volume: 10 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
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