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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Each Vascular Solutions D-Stat® flowable hemostat (D-Stat) includes the following components: Thrombin vial (5,000 units); Collagen (200mg), contained in 10ml syringe with attached mixing luer; Diluent vial (5ml); Mixing accessories (10ml syringe and needleless, non-coring vial access device); Applicator tips: (1) small bore tip, (1) 20-Gauge, 2.75" needle. The thrombin is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine-origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the thrombin vial are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The material contains no preservative and has been chromatographically purified. Thrombin requires no intermediate physiological agent for its reaction. It converts fibrinogen directly to fibrin. The collagen is a soft, white, pliable, absorbent hemostatic agent derived from purified bovine deep flexor tendon. It is prepared in a loose fibrous form. Collagen attracts platelets that adhere to the fibrils and undergo the release phenomenon to trigger aggregation of platelets into thrombi in the interstices of the fibrous mass. The collagen provides a three-dimensional matrix for additional strengthening of the clot. The effect on platelet adhesion and aggregation is not inhibited by heparin in vitro. The diluent is a sterile solution of calcium chloride and water, buffered with tromethamine (TRIS). Using the mixing accessories, both the thrombin and collagen are reconstituted with the diluent prior to use. The hemostat is delivered to the intended treatment site using the provided applicator tips. Hemostasis is achieved by the physiological coagulation-inducing properties of the D-Stat. The D-Stat is biocompatible, non-pyrogenic, and intended to be left in situ.
Vascular Solutions, Inc.
4000
In Commercial Distribution

  • M20640000 ()
  • M20640001 ()


  • Collagen haemostatic agent, non-antimicrobial
Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system
PACKING BLOCK FOR ZERO-P IMPLANTS
Synthes GmbH
03.617.984
In Commercial Distribution

  • 07611819969780 ()
  • H981036179840 ()
  • 10705034717388 ()
03617984

  • Bone graft packing block
ALIF GRAFT PACKING BLOCK
Synthes GmbH
389.155
In Commercial Distribution

  • H9813891550 ()
  • 10705034774800 ()
389155

  • Bone graft packing block
ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block
SYNFIX® EVOLUTION IMPLANT PACKING STATION
Synthes GmbH
03.835.050
In Commercial Distribution

  • 07611819658172 ()
  • H981038350500 ()
  • 10705034814193 ()
03835050

  • Bone graft packing block
PACKING BLOCK FOR ZERO-P VA IMPLANTS
Synthes GmbH
03.647.984
In Commercial Distribution

  • 07611819404502 ()
  • H981036479840 ()
  • 10705034720838 ()
03647984

  • Bone graft packing block
GRAFT PACKING BLOCK
Synthes GmbH
03.841.055
In Commercial Distribution

  • 07611819473140 ()
  • H981038410550 ()
  • 10705034732350 ()
03841055

  • Bone graft packing block
GRAFT PACKING BLOCK-LARGE FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.074
In Commercial Distribution

  • 07611819534780 ()
  • H981038250740 ()
  • 10705034732053 ()
03825074

  • Bone graft packing block
GRAFT PACKING BLOCK-MEDIUM FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.073
In Commercial Distribution

  • 07611819534773 ()
  • H981038250730 ()
  • 10705034732046 ()
03825073

  • Bone graft packing block
GRAFT PACKING BLOCK-SMALL FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.072
In Commercial Distribution

  • 07611819534766 ()
  • H981038250720 ()
  • 10705034732039 ()
03825072

  • Bone graft packing block
PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.042
Not in Commercial Distribution

  • 07611819297425 ()
  • H981038020420 ()
  • 10705034722276 ()
03802042

  • Bone graft packing block
PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.041
Not in Commercial Distribution

  • 07611819791268 ()
  • H981038020410 ()
  • 10705034722269 ()
03802041

  • Bone graft packing block
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1801
In Commercial Distribution

  • M7161111818010 ()
111-18-1801

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1601
In Commercial Distribution

  • M7161111816010 ()
111-18-1601

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1501
In Commercial Distribution

  • M7161111815010 ()
111-18-1501

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1500
In Commercial Distribution

  • M7161111815000 ()
111-18-1500

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1401
In Commercial Distribution

  • M7161111814010 ()
111-18-1401

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1400
In Commercial Distribution

  • M7161111814000 ()
111-18-1400

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1301
In Commercial Distribution

  • M7161111813010 ()
111-18-1301

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1201
In Commercial Distribution

  • M7161111812010 ()
111-18-1201

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1101
In Commercial Distribution

  • M7161111811010 ()
111-18-1101

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1001
In Commercial Distribution

  • M7161111810010 ()
111-18-1001

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1000
In Commercial Distribution

  • M7161111810000 ()
111-18-1000

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0901
In Commercial Distribution

  • M7161111809010 ()
111-18-0901

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0900
In Commercial Distribution

  • M7161111809000 ()
111-18-0900

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 8, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0800
In Commercial Distribution

  • M7161111808000 ()
111-18-0800

  • Press-fit femoral stem prosthesis
Origin R Broach Size 18
ORTHOMEDFLEX LLC
112-44-1118
In Commercial Distribution

  • M7161124411180 ()


  • Orthopaedic broach
Origin R Broach Size 16
ORTHOMEDFLEX LLC
112-44-1116
In Commercial Distribution

  • M7161124411160 ()


  • Orthopaedic broach
Origin R Broach Size 15
ORTHOMEDFLEX LLC
112-44-1115
In Commercial Distribution

  • M7161124411150 ()


  • Orthopaedic broach
Origin R Broach Size 14
ORTHOMEDFLEX LLC
112-44-1114
In Commercial Distribution

  • M7161124411140 ()


  • Orthopaedic broach
Origin R Broach Size 13
ORTHOMEDFLEX LLC
112-44-1113
In Commercial Distribution

  • M7161124411130 ()


  • Orthopaedic broach
Origin R Broach Size 12
ORTHOMEDFLEX LLC
112-44-1112
In Commercial Distribution

  • M7161124411120 ()


  • Orthopaedic broach
Origin R Broach Size 11
ORTHOMEDFLEX LLC
112-44-1111
In Commercial Distribution

  • M7161124411110 ()


  • Orthopaedic broach
Origin R Broach Size 10
ORTHOMEDFLEX LLC
112-44-1110
In Commercial Distribution

  • M7161124411100 ()


  • Orthopaedic broach
Origin R Broach Size 9
ORTHOMEDFLEX LLC
112-44-1109
In Commercial Distribution

  • M7161124411090 ()


  • Orthopaedic broach
Origin R Broach Size 8
ORTHOMEDFLEX LLC
112-44-1108
In Commercial Distribution

  • M7161124411080 ()


  • Orthopaedic implant impactor, reusable
Origin Instant Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81026-OD-EI
In Commercial Distribution

  • B77881026ODEI0 ()
81026-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81025-OD-EI
In Commercial Distribution

  • B77881025ODEI0 ()
81025-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
80902-OD-EI
In Commercial Distribution

  • B77880902ODEI0 ()
80902-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80600-OD-EI
In Commercial Distribution

  • B77880600ODEI0 ()
80600-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80510-OD-EI
In Commercial Distribution

  • B77880510ODEI0 ()
80510-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80502-OD-EI
In Commercial Distribution

  • B77880502ODEI0 ()
80502-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80409-OD-EI
In Commercial Distribution

  • B77880409ODEI0 ()
80409-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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