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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PreFAB-4 Blank with Screw compatible with Zimmer Screw-Vent 4.5 Wide D16
Biodenta Swiss AG
CAD-TPZSV45WS
In Commercial Distribution

  • 07640169731983 ()
CAD-TPZSV45WS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Zimmer Screw-Vent 4.5 Narrow D9.9
Biodenta Swiss AG
CAD-TPZSV45NS
In Commercial Distribution

  • 07640169731976 ()
CAD-TPZSV45NS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Zimmer Screw-Vent 3.5 Wide D16
Biodenta Swiss AG
CAD-TPZSV35WS
In Commercial Distribution

  • 07640169731969 ()
CAD-TPZSV35WS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Zimmer Screw-Vent 3.5 Narrow D9.9
Biodenta Swiss AG
CAD-TPZSV35NS
In Commercial Distribution

  • 07640169731952 ()
CAD-TPZSV35NS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Active RP Wide D16
Biodenta Swiss AG
CAD-TPNARPWS
In Commercial Distribution

  • 07640169731839 ()
CAD-TPNARPWS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Active RP Narrow D9.9
Biodenta Swiss AG
CAD-TPNARPNS
In Commercial Distribution

  • 07640169731822 ()
CAD-TPNARPNS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Active NP Wide D16
Biodenta Swiss AG
CAD-TPNANPWS
In Commercial Distribution

  • 07640169731815 ()
CAD-TPNANPWS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Active NP Narrow D9.9
Biodenta Swiss AG
CAD-TPNANPNS
In Commercial Distribution

  • 07640169731808 ()
CAD-TPNANPNS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Replace 6.0 Wide D16
Biodenta Swiss AG
CAD-TPNR60WS
In Commercial Distribution

  • 07640169731792 ()
CAD-TPNR60WS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Replace WP Narrow D9.9
Biodenta Swiss AG
CAD-TPNRWPNS
In Commercial Distribution

  • 07640169731778 ()
CAD-TPNRWPNS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Replace RP Wide D16
Biodenta Swiss AG
CAD-TPNRRPWS
In Commercial Distribution

  • 07640169731761 ()
CAD-TPNRRPWS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Replace RP Narrow D9.9
Biodenta Swiss AG
CAD-TPNRRPNS
In Commercial Distribution

  • 07640169731754 ()
CAD-TPNRRPNS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Nobel Replace NP Narrow D9.9
Biodenta Swiss AG
CAD-TPNRNPNS
In Commercial Distribution

  • 07640169731747 ()
CAD-TPNRNPNS

  • Dental implant suprastructure, permanent, preformed
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
Closed Wound Drain, Round, Silicone, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3640ATSR
In Commercial Distribution

  • M6653640ATSR3 ()
  • M6653640ATSR1 ()
  • M6653640ATSR0 ()

  • 7 FR


  • Closed-wound drain, non-bioabsorbable
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100040ATSC
In Commercial Distribution

  • M665100040ATSC3 ()
  • M665100040ATSC1 ()
  • M665100040ATSC0 ()

  • 40 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100036ATSC
In Commercial Distribution

  • M665100036ATSC3 ()
  • M665100036ATSC1 ()
  • M665100036ATSC0 ()

  • 36 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100028ATSC
In Commercial Distribution

  • M665100028ATSC3 ()
  • M665100028ATSC1 ()
  • M665100028ATSC0 ()

  • 28 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100016ATSC
In Commercial Distribution

  • M665100016ATSC3 ()
  • M665100016ATSC1 ()
  • M665100016ATSC0 ()

  • 16 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100014ATSC
In Commercial Distribution

  • M665100014ATSC3 ()
  • M665100014ATSC1 ()
  • M665100014ATSC0 ()

  • 14 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100010ATSC
In Commercial Distribution

  • M665100010ATSC3 ()
  • M665100010ATSC1 ()
  • M665100010ATSC0 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100008ATSC
In Commercial Distribution

  • M665100008ATSC3 ()
  • M665100008ATSC1 ()
  • M665100008ATSC0 ()

  • 8 FR


  • Pleural catheter
HOOK RETRACTOR WITH THUMB RING MINIATURE MODEL WITH FOUR IN-LINE PRONGS
SONTEC INSTRUMENTS, INC.
475-518
In Commercial Distribution

  • 00192896042384 ()

  • Length: 4.5 Inch
475-518

  • Hand-held surgical retractor, reusable
HOOK RETRACTOR WITH THUMB RING MINIATURE MODEL WITH FOUR IN-LINE PRONGS
SONTEC INSTRUMENTS, INC.
475-517
In Commercial Distribution

  • 00192896042377 ()

  • Length: 2.5 Inch
475-517

  • Hand-held surgical retractor, reusable
LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
TP ORTHODONTICS INC
298-807F
In Commercial Distribution

  • 00192029006474 ()


  • Orthodontic bracket, ceramic
UPPER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
TP ORTHODONTICS INC
298-801F
In Commercial Distribution

  • 00192029006436 ()


  • Orthodontic bracket, ceramic
PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm
Klarity Medical Products, LLC
R902-3A
In Commercial Distribution

  • 00817355023758 ()


  • Patient positioning thermoplastic mould material
MICASEPT BIOPSY AND GRASPING FORCEPS WITH 2 FANGS WITH HEGAR RATCHET
SONTEC INSTRUMENTS, INC.
20920-06-004
Not in Commercial Distribution

  • B09920920060040 ()

  • Length: 300 Millimeter
  • 4.5mm Diameter


  • Open-surgery biopsy forceps, reusable
MICASEPT BIOPSY AND GRASPING FORCEPS WITH 2 FANGS WITH ROUND RATCHET
SONTEC INSTRUMENTS, INC.
20920-06
Not in Commercial Distribution

  • B09920920060 ()

  • Length: 300 Millimeter
  • Lumen/Inner Diameter: 4.5 Millimeter


  • Open-surgery biopsy forceps, reusable
19 FR Round Fluted, Full with Trocar with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0504TK1
In Commercial Distribution

  • 00812269030540 ()
  • 00812269030533 ()


  • Closed-wound drainage kit
Roll-By With Adult Latex Calibrated V-Lok Inflation System With Circular Basket
W. A. BAUM CO., INC.
1150
In Commercial Distribution

  • 00810010920317 ()
1150

  • Aneroid manual sphygmomanometer
Flexi-Seal® Signal FMS Kit With 3 Bags With Charcoal Filter
CONVATEC, PURCHASING DEPARTMENT
418000
In Commercial Distribution

  • 00768455117178 ()
  • 10768455117175 ()


  • Faecal incontinence kit
Rechargable ophthalmoscope Set,with 489 handle,with DT801 charger,Zipper bag
Zumax Medical Co., LTD
DM6D
In Commercial Distribution

  • 06945095511182 ()


  • Direct ophthalmoscope
With inflation bag, Double tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BD-WD11
In Commercial Distribution

  • 06970706369081 ()


  • Blood pressure cuff, reusable
With inflation bag, Double tube, With connector Small Adult Range 17-25cm
Orantech Inc.
BP-40BD-WD11
In Commercial Distribution

  • 06970706369050 ()


  • Blood pressure cuff, reusable
With inflation bag, Double tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BD-W1011
In Commercial Distribution

  • 06970706368992 ()


  • Blood pressure cuff, reusable
With inflation bag, Double tube, With connector Small Adult Range 17-25cm
Orantech Inc.
BP-40BD-W1011
In Commercial Distribution

  • 06970706368961 ()


  • Blood pressure cuff, reusable
With inflation bag, Double tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BD-WD08
In Commercial Distribution

  • 06970706368909 ()


  • Blood pressure cuff, reusable
With inflation bag, Double tube, With connector Small Adult Range 17-25cm
Orantech Inc.
BP-40BD-WD08
In Commercial Distribution

  • 06970706368879 ()


  • Blood pressure cuff, reusable
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