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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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BISICO Repo-Core DC A3 Mini - EBIB752001

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75200
In Commercial Distribution

  • EBIB752001 ()
75200

  • Dental composite resin

BISICO Cementime DC - EBIB037301

Dual-curing, semipermanent luting cement for crowns and bridges on dental implants
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03730
In Commercial Distribution

  • EBIB037301 ()
03730

  • Ethoxy benzoic acid dental cement

BISICO Cem DC A3 - EBIB752401

Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of crowns, bridges, inlays and endodontic posts made of carbon fibers and glass fibers. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75240
In Commercial Distribution

  • EBIB752401 ()
75240

  • Dental composite resin

Research and Diagnostic Systems - 00815762021671

Quantikine Erythropoietin Control 1 & 2 (5 vials of each)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
CEP01
In Commercial Distribution

  • 00815762021671 ()
CEP01

  • Erythropoietin (EPO) IVD, control

Arthrex Calcium Sulfate BioBeads, 20 cc - 00850018568180

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-20
In Commercial Distribution

  • 00850018568180 ()

  • Total Volume: 20 Milliliter
ABS-3000-20

  • Bone matrix implant, synthetic, non-antimicrobial

Acrylic Spheres 20 mm, 3.6 cc - 10697660000357

Acrylic spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.6 Milliliter


  • Orbital sphere implant

Silicone Spheres (20 mm, 4.2 cc) - 10697660000258

Silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-220
Not in Commercial Distribution


  • Total Volume: 4.2 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant

Acrylic Spheres 20 mm, 3.6 cc - M8721132001

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution

  • M8721132001 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant

Silicone Spheres (20 mm, 4.2 cc) - M8721122000

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-220
Not in Commercial Distribution

  • M8721122000 ()

  • Outer Diameter: 20 Millimeter
  • Total Volume: 4.2 Milliliter


  • Orbital sphere implant

Disposable Electrode Serie - 06924274950554

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥW-B012注吹球
In Commercial Distribution

  • 06924274950554 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

Disposable Electrode Serie - 06924274950301

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥM-N007注针形
In Commercial Distribution

  • 06924274950301 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

ZOLL-DENTAL - 00840105207412

#20
Zoll-Dental
OPHOE-20
In Commercial Distribution

  • 00840105207412 ()


  • Periodontal hoe

ZOLL-DENTAL - 00840105202271

#20
Zoll-Dental
ELE-20
In Commercial Distribution

  • 00840105202271 ()


  • Dental elevator, tooth/root

SMMS - D830SW2020

STERILIZATION WRAP 20" X 20"
AMD Medicom Inc
SW2020
Not in Commercial Distribution

  • D830SW20201 ()
  • D830SW2020 ()


  • Sterilization packaging, single-use

Z-Staple - 04057217003818

Z-Staple 20 / 20 / 10 mm
Z-Medical GmbH + Co. KG
C03 263
In Commercial Distribution

  • 04057217003818 ()


  • Orthopaedic bone staple, non-adjustable

Z-Staple - 04057217003801

Z-Staple 20 / 20 / 7,5 mm
Z-Medical GmbH + Co. KG
C03 262
In Commercial Distribution

  • 04057217003801 ()


  • Orthopaedic bone staple, non-adjustable

Z-Staple - 04057217003795

Z-Staple 20 / 20 / 5 mm
Z-Medical GmbH + Co. KG
C03 261
In Commercial Distribution

  • 04057217003795 ()


  • Orthopaedic bone staple, non-adjustable

Z-Staple - 04057217003788

Z-Staple 20 / 20 / 2,5 mm
Z-Medical GmbH + Co. KG
C03 260
In Commercial Distribution

  • 04057217003788 ()


  • Orthopaedic bone staple, non-adjustable

Axiom - 00840363302782

Positioning Cushion 20 x 20
KI MOBILITY, LLC
P
In Commercial Distribution

XP2020

  • Wheelchair seat cushion

Automation Tween 20, 20X - 00847627014627

Alternate name : 20% Tween 20
BIOCARE MEDICAL LLC
TWA20M
In Commercial Distribution

  • 00847627014627 ()


  • Immunohistochemistry wash buffer reagent IVD

KIMGUARD™ KC100 Sterilization Wrap - 00036000107203

20" x 20" Sterilization Wrap
KIMBERLY-CLARK GLOBAL SALES, LLC
10720
In Commercial Distribution

  • 00036000107203 ()
  • 90036000107206 ()
  • 10036000107200 ()


  • Sterilization packaging, single-use

Diagnostic Medical - G373DM20200

20 x 20 mm Loop
Zinnanti Surgical Design Group Inc
DM2020
In Commercial Distribution

  • G373DM20200 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

Defend - 90816577021606

STERILIZATION WRAP 20'' X 20''
YOUNG MYDENT, LLC
SW-2000
In Commercial Distribution

  • 90816577021606 ()


  • Sterilization packaging, single-use

Star - 07320450175596

20 x 20 x 5
Etac Supply Center AB
Starlock 51X51X13 cm
In Commercial Distribution

  • 07320450175596 ()
ESSL52020-1N

  • Air-filled chair cushion

Star - 07320450175589

20 x 20 x 5
Etac Supply Center AB
Starlock 51X51X13 cm
In Commercial Distribution

  • 07320450175589 ()
ESSL52020-1IZ

  • Air-filled chair cushion

Star - 07320450175565

20 x 20 x 5
Etac Supply Center AB
Starlock 51X51X13 cm
In Commercial Distribution

  • 07320450175565 ()
ESSL52020-1

  • Air-filled chair cushion

Star - 07320450169243

20 x 20 x 5
Etac Supply Center AB
Stabil-Air Cushion
In Commercial Distribution

  • 07320450169243 ()
ESSA52020-1

  • Air-filled chair cushion

AADCO - 00840348525717

STERILE DISPOSABLE BAND BAGS 20" X 20" (20/CS)
AADCO MEDICAL, INC.
DB-2020
In Commercial Distribution

  • 00840348525946 ()
  • 00840348525717 ()
DB-2020

  • Sterilization packaging, single-use

IdentiTi - 00190376386164

LIF, DISTRACTOR, CC OFFSET, 4 x 20 x 60, 0°
ALPHATEC SPINE, INC.
255-12-04206000
In Commercial Distribution

  • 00190376386164 ()

  • Height: 4 Millimeter
  • Width: 20 Millimeter
  • Depth: 60 Millimeter


  • Bone lever/elevator, reusable

IQ Dental - 00816519022613

ATI Absorbent Points CC Bulk .02 Size 20 Box/200
IQ DENTAL SUPPLY LLC
ATI-AP02/20B
In Commercial Distribution

  • 00816519022613 ()
ATI-AP02/20B

  • Endodontic paper point

OPT CROUTONS - M505650220S0

Phosphocalcic ceramic
KASIOS
65-0220-S
In Commercial Distribution

  • M505650220S0 ()

  • 2-3 mm – 20 cc


  • Synthetic bone graft

CELLPLEX - 00840420134257

No Description
WRIGHT MEDICAL TECHNOLOGY, INC.
89000020
In Commercial Distribution

  • 00840420134257 ()

  • Total Volume: 20 cc
89000020

  • Bone matrix implant, synthetic, non-antimicrobial

EndoCurette - H671CUR1200

Endometrial Suction Curette with Syringe
UTAH MEDICAL PRODUCTS, INC.
Clear
In Commercial Distribution

  • H671CUR1201 ()
  • H671CUR1200 ()

  • Syringe Volume - 20 cc
  • Length: 27 Centimeter
  • Outer Diameter: 3.1 Millimeter
CUR-120

  • Endometrial biopsy curette

VP 1 + VP 2 - 03573026099626

VP1 VP2 are reagents associated to API 20 E™ (20 100/20 160), RapiD 20 E™ (20 701), API® Staph (20 500), API® 20 Strep (20 600)
BIOMERIEUX SA
70422
In Commercial Distribution

  • 03573026099626 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent

n.a. - 04048551095287

Probe, 3 mm, 20 cm, 20°
Karl Storz GmbH & Co. KG
28140TB
In Commercial Distribution

  • 04048551095287 ()


  • Endoscopic surgical probe

n.a. - 04048551183502

Curette, curved 20°, small, 20 cm
Karl Storz GmbH & Co. KG
629706
In Commercial Distribution

  • 04048551183502 ()


  • Open-surgery dissector

Axiom - 00840363301785

General Use Cushion 20 x 20
KI MOBILITY, LLC
G
In Commercial Distribution

XG2020

  • Wheelchair seat cushion

Axiom - 00840363302287

Skin Protection Cushion 20 x 20
KI MOBILITY, LLC
S
In Commercial Distribution

XS2020

  • Wheelchair seat cushion

Quala - D023Q6023351

Quala CSR Wrap 20 X 20
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q602335
In Commercial Distribution

  • D023Q6023353 ()
  • D023Q6023351 ()
Q602335

  • Sterilization packaging, single-use

Spex Limited - 09420051733435

SuperShape outer cover 20" x 20"
SPEX LIMITED
1256-2020-0SS-C
In Commercial Distribution

  • 09420051733435 ()


  • Wheelchair back rest

Henry Schein - H65890015861

20/20 Dentin/Enamel Light-Curing Bond
HENRY SCHEIN, INC.
9001586
In Commercial Distribution

  • H65890015861 ()
  • H65890015868 ()
9001586

  • Light-cured dental restorative composite resin

Henry Schein - H65890010200

20/20 Light Curing Hybrid Composite
HENRY SCHEIN, INC.
9001020
In Commercial Distribution

  • H65890010200 ()
9001020

  • Light-cured dental restorative composite resin

SPS Medical - 10732224730827

Disposable CSR Wrap - 20" x 20"
SPS Medical Supply Corp.
ESW-8920
In Commercial Distribution

  • 10732224730827 ()
  • 00732224730820 ()

  • Length: 20 Inch
ESW-8920

  • Sterilization packaging, single-use

Health-Tec Sterilization Wrap - D773590100111

Health-Tec Sterilization Wrap 20" X 20"
Dental Health Products Inc
590-10011
In Commercial Distribution

  • D773590100111 ()
  • D773590100110 ()
  • D773590100115 ()

  • Area/Surface Area: 20 Square inch
590-10011

  • Sterilization packaging, single-use

Arthrex® - 00888867346147

Modular Drill, 20° Full, 20 mm
ARTHREX, INC.
AR-9596-2020F
In Commercial Distribution

  • 00888867346147 ()
AR-9596-2020F

  • Cannulated surgical drill bit, reusable

2020 Imaging Podiatry System - 00817100020131

20/20 BiDirectional PDR X-ray Machine.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR400i
In Commercial Distribution

  • 00817100020131 ()
BD715

  • Stationary basic diagnostic x-ray system, digital

STERIMED, INC. - 00815588025730

STERISHEET RF 60I 20 X 20
STERIMED INC.
1010260I2020RF
In Commercial Distribution

  • 00815588025747 ()
  • 00815588025730 ()
1010260I2020RF

  • Sterilization packaging, single-use

Soule Medical - 00810082221701

Bean Bag Positioner - 20" x 20"
SOULE CO., THE
BBP2020
In Commercial Distribution

  • 00810082221701 ()
BBP2020

  • Freestanding patient positioner, reusable

CUSTOMED - M2089000812

STERILIZATION WRAPPER DISPOSABLE 20" X 20"
CUSTOMED INC
712057470020
In Commercial Distribution

  • M2089000812 ()
  • M2089000810 ()

  • 20" X 20"
900081

  • Sterilization packaging, single-use

MEDLINE - 10197344013043

360 - 360I 20"/20" LBSP 12RA
MEDLINE INDUSTRIES, INC.
613360501
In Commercial Distribution

  • 20197344013040 ()
  • 10197344013043 ()
  • 30197344013047 ()
613360501

  • Angiography kit
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