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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Mini Stealth All-Suture Anchor, with one #2 Suture
RESPONSIVE ORTHOPEDICS LLC
285951
In Commercial Distribution

  • 00811714036397 ()
285951

  • Tendon/ligament bone anchor, non-bioabsorbable
Mini Stealth All-Suture Anchor, with one #2 Suture
RESPONSIVE ORTHOPEDICS LLC
911000-0001
In Commercial Distribution

  • 00811714035796 ()
911000-0001

  • Tendon/ligament bone anchor, non-bioabsorbable
Mustang Suture Anchor, 4.5mm with one suture tape
RESPONSIVE ORTHOPEDICS LLC
916000-4500
In Commercial Distribution

  • 00811714035598 ()
916000-4500

  • Tendon/ligament bone anchor, non-bioabsorbable
Specialty Xia 3 One Handed Release Rod Gripper
Stryker Corporation
IS4378XLP
In Commercial Distribution

  • 07613327422238 ()
IS4378XLP

  • General internal orthopaedic fixation system implantation kit
Capsule Retractor, one prong, 20mm wide, 10” (25.4cm)
BOSS INSTRUMENTS, LTD., INC.
77-0819
In Commercial Distribution

  • 00888515200654 ()
77-0819

  • Hand-held surgical retractor, reusable
Integra® Duo Duo Battery Holster - Quantity One
INTEGRA LIFESCIENCES (IRELAND) LIMITED
90621
In Commercial Distribution

  • 10381780491071 ()
90621

  • General-purpose light source
HEEL/ELBOW PROTECTOR, Heel/Elbow Protector (One Size)
Walgreen Health Solutions, LLC
831727004114
In Commercial Distribution

  • G0648317270041140 ()
831727004114

  • Elbow/ankle friction/impact protector
ELBOWLIFT® Suspension Pad, Elbow Protector. One Size.
Walgreen Health Solutions, LLC
10831727009000
In Commercial Distribution

  • G064108317270090000 ()
10831727009000

  • Elbow/ankle friction/impact protector
GUIDED SURGERY PIVOT PREMIUM ONE, M1.80, SLEEVE 550
SWEDEN & MARTINA SPA
GS-PRN-AS-M18-550
In Commercial Distribution

  • D7701515683 ()
GS-PRN-AS-M18-550

  • Fixture/appliance dental drill bit, reusable
GUIDED SURGERY PIVOT PREMIUM ONE, M1.80, SLEEVE 415
SWEDEN & MARTINA SPA
GS-PRN-AS-M18-415
In Commercial Distribution

  • D7701515673 ()
GS-PRN-AS-M18-415

  • Fixture/appliance dental drill bit, reusable
SURGICAL KIT FOR PRE/KOH ONE IMPLANT SYSTEM
SWEDEN & MARTINA SPA
ZPREKOH-ONE-INT
In Commercial Distribution

  • D7701330763 ()
ZPREKOH-ONE-INT

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
545CV WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE - SNGL
EHOB INC
REV00
In Commercial Distribution

  • 30603354300607 ()
  • 10603354300184 ()
5450CVXX010

  • Heel protector
545CX WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE - SNGL
EHOB INC
REV00
In Commercial Distribution

  • 30603354300454 ()
  • 10603354300122 ()
5450CXXX010

  • Heel protector
Size: 6. Contains one each of 330601 & 341006.
Boston Medical Products, Inc.
330600
In Commercial Distribution

  • EBES3306001 ()

  • Outer Diameter (Cannula): 11 mm
  • Size: 6
  • Length (Cannula): 101 mm
  • Outer Diameter (Fenestrator): 8 mm
330600

  • Tracheostoma button
  • Tracheotome
Size: 10. Contains one each of 331001 & 341010.
Boston Medical Products, Inc.
331000
In Commercial Distribution

  • EBES3310001 ()

  • Outer Diameter (Cannula): 13 mm
  • Size: 10
  • Length (Cannula): 101 mm
  • Outer Diameter (Fenestrator): 11 mm
331000

  • Tracheostoma button
  • Tracheotome
Size: 8. Contains one each of 330801 & 341008.
Boston Medical Products, Inc.
330800
In Commercial Distribution

  • EBES3308001 ()

  • Outer Diameter (Fenestrator): 10 mm
  • Length (Cannula): 101 mm
  • Size: 8
  • Outer Diameter (Cannula): 12 mm
330800

  • Tracheotome
  • Tracheostoma button
Size: 4. Contains one each of 330401 & 341004.
Boston Medical Products, Inc.
330400
In Commercial Distribution

  • EBES3304001 ()

  • Outer Diameter (Fenestrator): 6.5 mm
  • Length (Cannula): 101 mm
  • Size: 4
  • Outer Diameter (Cannula): 9 mm
330400

  • Tracheotome
  • Tracheostoma button
LISTER BANDAGE SCISSORS, SUPERCUT, ONE LARGE RING, 8''
SURGIX MEDICAL LLC
G2G35913
In Commercial Distribution

  • 00840343714222 ()

  • Length: 8 Inch
G2G35913

  • Bandage scissors, reusable
Scissors, KELLY SUPERCUT one blade micro serrated 16cm
A. Schweickhardt GmbH & Co. KG
1143-400
In Commercial Distribution

  • E89611434000 ()
1143-400

  • General-purpose surgical scissors, reusable
EXPEDIUM SPINE SYSTEM SPINE PLATE NESTED, ONE SLOT
Medos International Sàrl
185465010
Not in Commercial Distribution

  • 10705034103174 ()
185465010

  • Spinal fixation plate, non-bioabsorbable
EXPEDIUM SPINE SYSTEM SPINE PLATE SMOOTH, ONE SLOT
Medos International Sàrl
185460010
Not in Commercial Distribution

  • 10705034101521 ()
185460010

  • Spinal fixation plate, non-bioabsorbable
EXPEDIUM SPINE SYSTEM ONE HANDED ROD APPROXIMATOR 5.5
Medos International Sàrl
279712510
In Commercial Distribution

  • 10705034198965 ()
279712510

  • Surgical instrument handle, non-torque-limiting
Good Neighbor Pharmacy One Step Ovulation Predictor 7ct
Amerisourcebergen Drug Corporation
One Step Ovulation Predictor
In Commercial Distribution

  • 10087701738316 ()
  • 00087701738319 ()
  • 00633472000140 ()


  • Natural conception assistance kit
MONARCH SPINE SYSTEM SPINE PLATE, ONE, HALF SLOT
DEPUY SPINE, LLC
177065040
Not in Commercial Distribution

  • 10705034057750 ()
177065040

  • Spinal fixation plate, non-bioabsorbable
MONARCH SPINE SYSTEM SPINE PLATE, ONE SLOT SHORT
DEPUY SPINE, LLC
177065005
Not in Commercial Distribution

  • 10705034057712 ()
177065005

  • Spinal fixation plate, non-bioabsorbable
MONARCH SPINE SYSTEM SPINE PLATE, ONE, HALF SLOT
DEPUY SPINE, LLC
177060040
Not in Commercial Distribution

  • 10705034057668 ()
177060040

  • Spinal fixation plate, non-bioabsorbable
MONARCH SPINE SYSTEM SPINE PLATE, ONE SLOT SHORT
DEPUY SPINE, LLC
177060005
Not in Commercial Distribution

  • 10705034057620 ()
177060005

  • Spinal fixation plate, non-bioabsorbable
NEO MINI CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.330-ET
In Commercial Distribution

  • 07899878029489 ()

  • Outer Diameter: 4.1 Millimeter
118.330-ET

  • Dental implant suprastructure, permanent, preformed
NEO MICRO CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.332-ET
In Commercial Distribution

  • 07899878030201 ()
118.332-ET

  • Dental implant suprastructure, permanent, preformed
NEO MICRO CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.332
In Commercial Distribution

  • 07899878028871 ()
118.332

  • Dental implant suprastructure, permanent, preformed
NEO MINI CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.330
In Commercial Distribution

  • 07899878028857 ()

  • Outer Diameter: 4.1 Millimeter
118.330

  • Dental implant suprastructure, permanent, preformed
ONE BY POISE SUPRPREM ULTRATHN HVYWNG PAD 18
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 10036000534501 ()
  • 00036000534504 ()
  • 00036000536829 ()


  • Menstrual pad, unscented
ONE BY POISE SUPRPREM ULTRATHN REGWNG PAD 22
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 10036000534495 ()
  • 00036000534498 ()
  • 00036000536829 ()


  • Menstrual pad, unscented
ONE BY POISE SUPRPREM XCVRG FLAT LINER 50
KIMBERLY-CLARK GLOBAL SALES, INC.
Pad
Not in Commercial Distribution

  • 10036000534488 ()
  • 00036000534481 ()
  • 00036000536836 ()


  • Menstrual pad, unscented
Care One TRUE METRIX Self-Monitoring Blood Glucose Meter
TRIVIDIA HEALTH, INC.
TRUE METRIX Self Monitoring Blood Glucose Meter
In Commercial Distribution

  • 00021292007690 ()
  • 10041520147742 ()
  • 00041520147745 ()


  • Glucose monitoring system IVD, home-use
All-purpose Smart-Heal Hydrocolloid Gel Bandages, all one size
Aso LLC
017276234787
In Commercial Distribution

  • 20017276234781 ()
  • 00017276234787 ()
  • 60017276234789 ()
017276234787

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
MINI CONICAL ABUTMENT ONE STEP HYB COPING 7MM
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.410-ET
In Commercial Distribution

  • 07899878064954 ()

  • Outer Diameter: 4.8 Millimeter
  • Height: 7.0 Millimeter
118.410-ET

  • Dental implant suprastructure, permanent, preformed
MINI CONICAL ABUTMENT ONE STEP HYB COPING 7MM
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.410
In Commercial Distribution

  • 07899878064947 ()

  • Outer Diameter: 4.8 Millimeter
  • Height: 7.0 Millimeter
118.410

  • Dental implant suprastructure, permanent, preformed
FRACTURED THREAD REMOVER (ONE PIECE/FLOATING SCREW ABUT)
JJGC Indústria e Comércio de Materiais Dentários S/A.
CD3032006
In Commercial Distribution

  • 07899878058601 ()
CD3032006

  • Screw extractor, single-use
NEO MINI CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.382-ET
In Commercial Distribution

  • 07899878056249 ()

  • Outer Diameter: 4.1 Millimeter
118.382-ET

  • Dental implant suprastructure, permanent, preformed
NEO MICRO CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118.381-ET
In Commercial Distribution

  • 07899878056232 ()
118.381-ET

  • Dental implant suprastructure, permanent, preformed
NEO MINI CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118382
In Commercial Distribution

  • 07899878056195 ()

  • Outer Diameter: 4.1 Millimeter
118382

  • Dental implant suprastructure, permanent, preformed
NEO MICRO CONICAL ABUTMENT ONE STEP HYBRID COPING
JJGC Indústria e Comércio de Materiais Dentários S/A.
118381
In Commercial Distribution

  • 07899878056188 ()
118381

  • Dental implant suprastructure, permanent, preformed
WALG Hot/Cold Knee/Ankle Support - One Size
WALGREEN CO.
973093
In Commercial Distribution

  • 00049022942585 ()
  • 10049022942582 ()


  • Hot/cold therapy pack, reusable
EXPEDIUM SPINE SYSTEM ONE HANDED ROD APPROXIMATOR 6.35
Medos International Sàrl
279712610
In Commercial Distribution

  • 10705034301358 ()
279712610

  • Surgical instrument handle, non-torque-limiting
ONE BOTTLE BOND Liquid Light Cure 6 ml
DARBY DENTAL SUPPLY, LLC
SDBK
In Commercial Distribution

  • 00889813001707 ()
9509082

  • Dentine adhesive
ONE PC MLD,10LD,MAC2000,BANANA,8',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-10DC-08AS-0042
In Commercial Distribution

  • 00840828187053 ()
28079

  • Electrocardiographic lead set, reusable
Andrew Suction, Vented Poole Tip one distal hole
Avalign Technologies, Inc.
72-13624
In Commercial Distribution

  • 00190776299774 ()


  • Surgical irrigation/aspiration cannula, non-illuminating, reusable
ONE PIECE MOLDED,5LD,GE,PINCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05NB-10AS-0002
In Commercial Distribution

  • 00840828161909 ()
22614

  • Electrocardiographic lead set, reusable
ONE PIECE MOLD,5LD,PHILIPS,PINCH,10',AHA
CURBELL MEDICAL PRODUCTS, INC.
MCB-05JB-10AS-0121
In Commercial Distribution

  • 00840828161640 ()
22545

  • Electrocardiographic lead set, reusable
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