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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ONE PIECE MOLDED,5LD,GE,PINCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05NB-10AS-0000
In Commercial Distribution

  • 00840828160131 ()
22123

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,5LD,GE,SNAP,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05NA-10AS-0000
In Commercial Distribution

  • 00840828160124 ()
22122

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,5LD,SPACELAB,SL,10',AH
CURBELL MEDICAL PRODUCTS, INC.
MCB-05MD-10AS-0030
Not in Commercial Distribution

  • 00840828160117 ()
22121

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,5LD,SPACEL,PNCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05MB-10AS-0030
In Commercial Distribution

  • 00840828160100 ()
22120

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,5LD,SPACELAB,SNAP,10',A
CURBELL MEDICAL PRODUCTS, INC.
MCB-05MA-10AS-0030
In Commercial Distribution

  • 00840828160094 ()
22119

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,5LD,PHILIPS,SL,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05JD-10AS-0120
Not in Commercial Distribution

  • 00840828160087 ()
22118

  • Electrocardiographic lead set, reusable
ONE PIECE MOLD,5LD,PHILIPS,PINCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05JB-10AS-0120
In Commercial Distribution

  • 00840828160070 ()
22117

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDE,5LD,PHILIPS,SNAP,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05JA-10AS-0120
In Commercial Distribution

  • 00840828160063 ()
22116

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,3LD,GE,PINCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-03NB-10AS-0010
In Commercial Distribution

  • 00840828160049 ()
22114

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,3LD,GE,SNAP,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-03NA-10AS-0010
In Commercial Distribution

  • 00840828160032 ()
22113

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,3LD,SPACELAB,SL,10',AH
CURBELL MEDICAL PRODUCTS, INC.
MCB-03MD-10AS-0030
Not in Commercial Distribution

  • 00840828160025 ()
22112

  • Electrocardiographic lead set, reusable
ONE PIECE MOLD,3LD,SPACELAB,PINCH,10',AH
CURBELL MEDICAL PRODUCTS, INC.
MCB-03MB-10AS-0030
In Commercial Distribution

  • 00840828160018 ()
22111

  • Electrocardiographic lead set, reusable
ONE PIECE MOLD,3LD,SPACELABS,SNAP,10',AH
CURBELL MEDICAL PRODUCTS, INC.
MCB-03MA-10AS-0030
In Commercial Distribution

  • 00840828160001 ()
22110

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDED,3LD,PHILIPS,SL,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-03JD-10AS-0120
Not in Commercial Distribution

  • 00840828159999 ()
22109

  • Electrocardiographic lead set, reusable
ONE PIECE MOLD,3LD,PHILIPS,PINCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-03JB-10AS-0120
In Commercial Distribution

  • 00840828159982 ()
22108

  • Electrocardiographic lead set, reusable
ONE PIECE MOLDE,3LD,PHILIPS,SNAP,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-03JA-10AS-0120
In Commercial Distribution

  • 00840828159975 ()
22107

  • Electrocardiographic lead set, reusable
Tubing, 7 ft., with One Hose End, Bulk
TELEFLEX INCORPORATED
IPN045166
In Commercial Distribution

  • 24026704580433 ()
  • 04026704580439 ()
7174

  • Oxygen administration tubing
mAMP One Step methamphetamine Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DMA-114
In Commercial Distribution

  • 10815845020468 ()
  • 00815845020461 ()
4011760099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC300/THC50)
ALERE SAN DIEGO, INC.
DOA-124
In Commercial Distribution

  • 10815845020567 ()
  • 00815845020560 ()
4011910099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP One Step Buprenorphine Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DBU-114
In Commercial Distribution

  • 10815845020406 ()
  • 00815845020409 ()
4081730099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MTD One Step Methadone Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DMT-114
In Commercial Distribution

  • 10815845020253 ()
  • 00815845020256 ()
4011820099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MOP One Step Opiate Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DMO-114
In Commercial Distribution

  • 10815845020239 ()
  • 00815845020232 ()
4011800099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDMA One Step Ecstacy Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DMD-114
In Commercial Distribution

  • 10815845020215 ()
  • 00815845020218 ()
4011780099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC One Step Cocaine Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DCO-114
In Commercial Distribution

  • 10815845020208 ()
  • 00815845020201 ()
4011740099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO One Step Benzodiazepines Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DBZ-114
In Commercial Distribution

  • 10815845020185 ()
  • 00815845020188 ()
4011720099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BAR One Step Barbiturates Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DBA-114
In Commercial Distribution

  • 10815845020161 ()
  • 00815845020164 ()
4011700099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP One Step Amphetamine Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DAM-114
In Commercial Distribution

  • 10815845020147 ()
  • 00815845020140 ()
4011680099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Critikon Soft Cuf One Tube Bayonet, Adult Long
HYGIA HEALTH SERVICES, INC.
2140
Not in Commercial Distribution

  • 30817357020398 ()
  • 10817357020394 ()


  • Blood pressure cuff, reprocessed
Critikon Soft Cuf One Tube Bayonet, Large Adult
HYGIA HEALTH SERVICES, INC.
2364
Not in Commercial Distribution

  • 30817357021081 ()
  • 10817357021087 ()


  • Blood pressure cuff, reprocessed
Critikon Soft Cuf One Tube Bayonet, Small Adult
HYGIA HEALTH SERVICES, INC.
2362
Not in Commercial Distribution

  • 30817357020985 ()
  • 10817357020981 ()


  • Blood pressure cuff, reprocessed
DENTAL PROBE WITH ONE SIDE MARKED 6 INCH
DR.FRIGZ INTERNATIONAL(PVT)LTD,
DENTAL PROBE
In Commercial Distribution

  • B974DP10200 ()

  • Length: 6 Inch
DP1020

  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use
"Robot stand reference clamp ROSA One spine application"
MEDTECH
174132-02
Not in Commercial Distribution

  • 03760244034120 ()
ROSAS00555

  • Multi-purpose stereotactic surgery system
"Robot stand reference clamp ROSA One spine application"
MEDTECH
174132-01
Not in Commercial Distribution

  • 03760244033581 ()
ROSAS00555

  • Multi-purpose stereotactic surgery system
ball hex driver 5 mm for Rosa One
MEDTECH
151024-01
Not in Commercial Distribution

  • 03760244033277 ()
ROSAS00189

  • Multi-purpose stereotactic surgery system
Robot stand reference clamp ROSA One spine application
MEDTECH
174132-00
Not in Commercial Distribution

  • 03760244032942 ()
ROSAS00555

  • Multi-purpose stereotactic surgery system
FLEX DRILL 3.2 X 25MM II ONE PIECE
Microport Orthopedics Inc.
8400FD13
In Commercial Distribution

  • M6848400FD131 ()
8400FD13

  • Joint prosthesis implantation kit, reusable
Bruns Shears 9 1/2" one serr blade
GSOURCE LLC
gS 15.9250
In Commercial Distribution

  • 00840314202710 ()
gS 15.9250

  • General-purpose surgical scissors, reusable
Ingrown Nail Splitting Scissors 6", one serr blade
GSOURCE LLC
gS 15.6600
In Commercial Distribution

  • 00840314202543 ()
gS 15.6600

  • General-purpose surgical scissors, reusable
STEEL, ELECTRIC, ONE SECTION TREATMENT TABLE WITH ARMREST
ARMEDICA MANUFACTURING CORP.
AM1010M
In Commercial Distribution

  • B866MAM1010M1 ()
  • B866PAM1010M1 ()
AM1010M

  • Examination/treatment table, line-powered
Coated Allis Bone Plate Clamp One End Coated
INNOMED, INC.
1381
In Commercial Distribution

  • 00840277117960 ()
381

  • Bone approximation clamp
Unger Offset Narrow Hohmann with One Tip Right
INNOMED, INC.
3009-R
In Commercial Distribution

  • 00840277105035 ()
3009-R

  • Hand-held surgical retractor, reusable
Unger Offset Narrow Hohmann with One Tip Left
INNOMED, INC.
3009-L
In Commercial Distribution

  • 00840277105028 ()
3009-L

  • Hand-held surgical retractor, reusable
Steel, electrical, one section treatment table without casters
ARMEDICA MANUFACTURING CORP.
AMTM100
In Commercial Distribution

  • B866PAMTM1001 ()
  • B866MAMTM1001 ()
AMTM100

  • Examination/treatment table, line-powered
MOSS VRS XT One Step Screw Inserter, Awl
Biedermann Motech GmbH & Co. KG
208-010-0133
In Commercial Distribution

  • 04250869691680 ()
208-010-0133

  • General internal orthopaedic fixation system implantation kit
MOSS VRS XT One Step Screw Inserter Handle
Biedermann Motech GmbH & Co. KG
208-010-0132
In Commercial Distribution

  • 04250869691673 ()
208-010-0132

  • General internal orthopaedic fixation system implantation kit
One person use unuversal(L) air pad 1ea
DAESUNG MAREF CO.,LTD.
CTCULDA
Not in Commercial Distribution

  • 18809315679692 ()
  • 08809315679695 ()
  • 28809315679699 ()
  • 38809315679696 ()


  • Circulating-fluid localized thermal therapy system pack, reusable
One person use universal(M) air pad 1ea
DAESUNG MAREF CO.,LTD.
CTCUMDA
Not in Commercial Distribution

  • 18809315679678 ()
  • 08809315679671 ()
  • 28809315679675 ()
  • 38809315679672 ()


  • Circulating-fluid localized thermal therapy system pack, reusable
6 chamber FULL BODY EXTENSION ZIPPER (One size)
DAESUNG MAREF CO.,LTD.
AC0634
Not in Commercial Distribution

  • 28809315679132 ()
  • 08809315679138 ()
  • 18809315679135 ()
  • 08809315679121 ()


  • Pneumatic massager
  • Multi-chamber venous compression system garment, reusable
2.5mm MiTi Suture Anchor w/ One #2 Suture
PARCUS MEDICAL LLC
10434
In Commercial Distribution

  • M685104340 ()

  • Outer Diameter: 3.5 Millimeter
10434

  • Tendon/ligament bone anchor, non-bioabsorbable
2.0mm MiTi Suture Anchor w/ One 2-0 Sutures
PARCUS MEDICAL LLC
10443T
In Commercial Distribution

  • M68510443T1 ()
  • M68510443T0 ()

  • Outer Diameter: 2.0 Millimeter
10443T

  • Tendon/ligament bone anchor, non-bioabsorbable
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