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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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PureSkin Latex Powder-Free, X-Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020105
In Commercial Distribution

  • D79010201050 ()
  • D79010201051 ()
1020105

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020104
In Commercial Distribution

  • D79010201040 ()
  • D79010201041 ()
1020104

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, X-Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020101
In Commercial Distribution

  • D79010201010 ()
  • D79010201011 ()
1020101

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, Medium, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020103
In Commercial Distribution

  • D79010201030 ()
  • D79010201031 ()
1020103

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
PureSkin Latex Powder-Free, Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020102
In Commercial Distribution

  • D79010201020 ()
  • D79010201021 ()
1020102

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Cottle Chisel, 7 1/4", 4mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410290
In Commercial Distribution

  • 00190776382223 ()


  • Plastic surgery osteotome
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1742
In Commercial Distribution

  • 04045396214590 ()
1742

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1743
In Commercial Distribution

  • 04045396208971 ()
1743

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1741
In Commercial Distribution

  • 04045396208858 ()
1741

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1740
In Commercial Distribution

  • 04045396208797 ()
1740

  • Automatic-inflation electronic sphygmomanometer, non-portable
kelman dipstick, 19-gauge cannula, marked at 5.0, 6.0, & 7.0 mm, 2 irrigating ports
NOVO SURGICAL, INC.
OP7120-38
In Commercial Distribution

  • G586OP7120380 ()
OP7120-38

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Vaginal Packing x ray detectable loop stitched at one end 2" x 72"
Dermapac Inc.
5551
In Commercial Distribution

  • 00810102270481 ()
  • 10810102270488 ()


  • Radiopaque woven surgical sponge
Adson Dura & Dissecting Hook 8" (20cm), sharp blade 5mm at a right angle
Hayden Medical, Inc.
210-168
In Commercial Distribution

  • 00840319744550 ()
210-168

  • Soft-tissue surgical hook, reusable
Potts-Smith Tissue Forceps 8-1/4" (20.6cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-162NC
In Commercial Distribution

  • 00840319739754 ()
120-162NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Cushing Bayonet Dressing Forceps 7-1/4" (18.4cm), serrated, non-conductive, exposed at both ends
Hayden Medical, Inc.
120-190NC
In Commercial Distribution

  • 00840319703656 ()
120-190NC

  • Dressing/utility forceps, tweezers-like, reusable
Gerald Tissue Forceps 7" (17.5cm), straight, 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-182NC
In Commercial Distribution

  • 00840319703618 ()
120-182NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Potts-Smith Tissue Forceps 9-1/2" (23.8cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-164NC
In Commercial Distribution

  • 00840319703557 ()
120-164NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Reverdin Suture Passing Needle 8-1/4" (21cm), curved with 2mm hole at tip
Hayden Medical, Inc.
405-698
In Commercial Distribution

  • 00840319751114 ()
405-698

  • Suture kit, medicated
Reverdin Suture Passing Needle 6" (15cm), slightly curved with 2mm hole at tip
Hayden Medical, Inc.
405-695
In Commercial Distribution

  • 00840319751084 ()
405-695

  • Suture kit, medicated
Cottle Chisel, 7 1/4", 9mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410292
In Commercial Distribution

  • 00190776402037 ()


  • Plastic surgery osteotome
Cottle Chisel, 7 1/4", 7mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410291
In Commercial Distribution

  • 00190776402020 ()


  • Plastic surgery osteotome
Reusable Bipolar Forceps with 0.7mm Tips Angled 45 Degrees Up at 1cm (Special)
KIRWAN SURGICAL PRODUCTS LLC
10-2402AUS
In Commercial Distribution

  • 00841019122297 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Osteotome, straight, concave, 2.0mm < 2.5mm, Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.01
In Commercial Distribution

  • 00841685100872 ()


  • Dental osteotome
Tweezers with the characteristics of the R-55 packing instrument incorporated at the tips.
PASCAL COMPANY, INC.
26200
In Commercial Distribution

  • 00310866002460 ()


  • Gingival retraction cord packing tool
Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 6-1/2in (16.5cm)
ELMED INCORPORATED
36-9153
In Commercial Distribution

  • 00842180199576 ()
36-9153

  • ENT surgical procedure kit, non-medicated, reusable
HOHMANN RETRACTOR, 13.25" OAL, 11 MM BLADE WIDTH AT END, EXTRA DEEP, BLUNT
ELMED INCORPORATED
ST23455001
In Commercial Distribution

  • 00842180196780 ()
ST23455001

  • Hand-held surgical retractor, reusable
HOHMANN RETRACTOR, 13.25" OAL, 11 MM BLADE WIDTH AT END, EXTRA DEEP, BLUNT
ELMED INCORPORATED
23-4550-01
In Commercial Distribution

  • 00842180171398 ()
23-4550-01

  • Hand-held surgical retractor, reusable
Multi-hole suction tubes, Five holes at tip. 7Fr. Working length 6-1/2in (16.5cm).
ELMED INCORPORATED
36-9154
In Commercial Distribution

  • 00842180187610 ()
36-9154

  • ENT surgical procedure kit, non-medicated, reusable
Multi-hole suction tubes, Five holes at tip. 7Fr. Working length 4-1/2in (11.4cm).
ELMED INCORPORATED
36-9152
In Commercial Distribution

  • 00842180187603 ()
36-9152

  • ENT surgical procedure kit, non-medicated, reusable
Contour-Flex Valve System, Small, High Pressure At 20 ml/hr: 12.7-18.0 cm H2O
NATUS MEDICAL INCORPORATED
NT14087
In Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT14087

  • Ventriculo-peritoneal/atrial shunt
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