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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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Zimmer - 08435457259275

Internal Hex "Click"
TERRATS MEDICAL SL.
88.016/5
In Commercial Distribution

  • 08435457259275 ()
ODS-CERT505

  • Dental implant suprastructure, permanent, preformed

DESS dental smart solutions - 08435457259213

Internal Hex "Click"
TERRATS MEDICAL SL.
88.015/5
In Commercial Distribution

  • 08435457259213 ()
ODS-CERT405

  • Dental implant suprastructure, permanent, preformed

DESS dental smart solutions - 08435457259152

Internal Hex "Click"
TERRATS MEDICAL SL.
88.014/5
In Commercial Distribution

  • 08435457259152 ()
ODS-CERT305

  • Dental implant suprastructure, permanent, preformed

Proform Hip System - 10840843100034

No Description
GLOBUS MEDICAL, INC.
SC1151-28MM -5
In Commercial Distribution

  • 10840843100034 ()


  • Metallic femoral head prosthesis

Switch-it - 00016958060850

The Ctrl+5 box allows you to easily access power seating controls right at your fingertips. Designed with five buttons or toggles, this box can be programmed to control up to 10 separate power seating functions! The Ctrl+5 is equipped with the R-NET bus connector, making setup a snap. Features a 4'8" (150 cm) cable with R-NET male bus connector.
SUNRISE MEDICAL (US) LLC
CTRL+5
In Commercial Distribution

  • 00016958060850 ()
SWI

  • Wheelchair steering/control unit

Supremo Instrumentos - 07908854001507

Extrator de implante Zigomatico 5,0
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S0691/5
In Commercial Distribution

  • 07908854001507 ()


  • Surgical screwdriver, reusable

SwissPlus® - 00889024016019

No Description
ZIMMER DENTAL INC.
OPT/5
In Commercial Distribution

  • 00889024016019 ()

  • Ø4.8mm, Ø5.2mm


  • Dental implant suprastructure, temporary, preformed, single-use

SwissPlus® - 00889024015739

No Description
ZIMMER DENTAL INC.
OPA/5
In Commercial Distribution

  • 00889024015739 ()

  • Ø4.8mm, Ø5.2mm


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® - 00889024015326

No Description
ZIMMER DENTAL INC.
HLT4/5
In Commercial Distribution

  • 00889024015326 ()


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® - 00889024015302

No Description
ZIMMER DENTAL INC.
HLT3/5
In Commercial Distribution

  • 00889024015302 ()

  • Ø3.5mm, Ø5.5mm


  • Dental implant suprastructure, temporary, preformed, single-use

Hex-Lock® - 00889024015210

No Description
ZIMMER DENTAL INC.
HLA4/5
In Commercial Distribution

  • 00889024015210 ()

  • Ø4.5mm, Ø5.5mm


  • Dental implant suprastructure, permanent, preformed

Hex-Lock® - 00889024015180

No Description
ZIMMER DENTAL INC.
HLA3/5
In Commercial Distribution

  • 00889024015180 ()

  • Ø3.5mm, Ø5.5mm


  • Dental implant suprastructure, permanent, preformed

Tapered Screw-Vent® - 00889024014619

No Description
ZIMMER DENTAL INC.
DHT4/5
In Commercial Distribution

  • 00889024014619 ()

  • Device Size Text, specify:


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® - 00889024014596

No Description
ZIMMER DENTAL INC.
DHT3/5
In Commercial Distribution

  • 00889024014596 ()

  • Ø3.5mm; Ø5.5mm


  • Dental implant suprastructure, temporary, preformed, single-use

Tapered Screw-Vent® Implant System - 00889024013759

No Description
ZIMMER DENTAL INC.
AH20W/5
In Commercial Distribution

  • 00889024013759 ()

  • Ø4.5mm, Ø5.5mm


  • Dental implant suprastructure, permanent, preformed

AMPLIM - 00810477026416

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177W-20+5
In Commercial Distribution

  • 00810477026416 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

AMPLIM - 00810477026287

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
AMPLIM, LLC
A8177-20+5
In Commercial Distribution

  • 00810477026287 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Symmetric Total Knee Tibial Tray - B04622021250

Symmetric Total Knee Tibial Tray Size 5
SIGNAL MEDICAL CORPORATION
Size: 5
In Commercial Distribution

  • B04622021250 ()
22-02-125

  • Coated unicondylar knee tibia prosthesis

Diamatrix - 00813059014757

Castroviejo Suturing Forceps, .5mm heavy 1x2 teeth, 5.5mm tying platform, Straight shafts, Flat serrated handle with lateral grooves, 109mm total length, Stainless
Diamatrix
F301S.5
In Commercial Distribution

  • 00813059014757 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Surround - 00812747010170

Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software

Trabexus® - W4146EB0005T0475

Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft

Smart-Read EZTest Steam - M985SEZS5251

Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator

ProSpore2 - M985PS235501

Self-contained biological indicator for use in steam sterilization. Log 5. 50 count package.
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS235501 ()
  • M985PS235500 ()
PS2-3-5-50

  • Biological sterilization indicator

ProSpore2 - M985PS2351

Biological Indicator intended for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box
MESA LABORATORIES, INC.
Log 5
Not in Commercial Distribution

  • M985PS2351 ()
  • M985PS23550 ()
PS2-3-5-50

  • Biological sterilization indicator

FifthPulse - 00810084936887

Instant Cold Pack
Jeg & Sons Inc.
5 Pack
In Commercial Distribution

  • 00810084938355 ()
  • 00810084936887 ()
FMN100525

  • Hot/cold therapy pack, single-use

PLUG T1 - 58032919891049

Plug T1 5 cm is a macroporous round preshaped flat plug, indicated for the treatment of inguinal hernia defect with open technique.
HERNIAMESH SRL
PT1/5
In Commercial Distribution

  • 18032919891041 ()
  • 58032919891049 ()


  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

NA - 08806088508931

Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
Grid 5
In Commercial Distribution

  • 08806088508931 ()


  • Stationary x-ray grid

NA - 10886982241313

TI ECCENTER-STERILE
SYNTHES (U.S.A.) LP
5413-20/5
Not in Commercial Distribution

  • H67954132050 ()
  • 10886982241313 ()
5413205

  • Shoulder humeral body prosthesis

MetaFix™ Open Wedge Locking Plate - 04048266135896

No Description
Merete GmbH
right 5
In Commercial Distribution

  • 04048266135896 ()

  • Wedge 5 mm
FH13005

  • Orthopaedic fixation plate, non-bioabsorbable

MetaFix™ Open Wedge Locking Plate - 04048266135865

No Description
Merete GmbH
left 5
In Commercial Distribution

  • 04048266135865 ()

  • Wedge 5 mm
FH12005

  • Orthopaedic fixation plate, non-bioabsorbable

A. Titan Instruments - 00841685106621

Periodontal Instrument, Scaler, double-ended
A. TITAN INSTRUMENTS, INC.
GF 5
In Commercial Distribution

  • 00841685106621 ()


  • Manual dental scaler, reusable

A. Titan Instruments - 00841685104733

Periotome Tip, Counter-angled
A. TITAN INSTRUMENTS, INC.
P 5
In Commercial Distribution

  • 00841685104733 ()


  • Periotome, reusable

A. Titan Instruments - 00841685103729

Sinus lift instrument, Sinus Elevator
A. TITAN INSTRUMENTS, INC.
Sinus 5
In Commercial Distribution

  • 00841685103729 ()


  • Dental elevator, sinus lift

A. Titan Instruments - 00841685103446

Carver, Tanner 5, double ended
A. TITAN INSTRUMENTS, INC.
Tanner 5
In Commercial Distribution

  • 00841685103446 ()


  • Dental restoration carver, amalgam, reusable

A. Titan Instruments - 00841685110062

Straight, 5mm, Red, D-Lux Elevator
A. TITAN INSTRUMENTS, INC.
Lux 5
In Commercial Distribution

  • 00841685110062 ()


  • Dental elevator, tooth/root

A. Titan Instruments - 00841685109530

Explorer, Double Ended
A. TITAN INSTRUMENTS, INC.
Expl 5
In Commercial Distribution

  • 00841685109530 ()


  • Dental surgical probe, reusable

Rexton - 04056839056707

Rexton Sterling 5 Hearing Aid
Ws Audiology Usa, Inc.
Sterling 5
In Commercial Distribution

  • 04056839056707 ()
10946848

  • Air-conduction hearing aid, in-the-ear

mahe medical GmbH - 04050659347335

Shaft knob,5mm _x000D_ _x000D_
mahe medical gmbh
19.80/5
In Commercial Distribution

  • 04050659347335 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Sterile Water for Inhalation, USP, 5 mL UDV - 00376204500050

No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204500050 ()
  • 00376204500999 ()


  • Inhalation therapy sterile water

Sodium Chloride Inhalation Solution, USP, 0.45% 5 mL UDV - 00376204400053

No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204400053 ()
  • 00376204400992 ()


  • Inhalation therapy saline solution, isotonic
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