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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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DETECTABUSE - 00810042682511

Menu CA, CUTOFF +50%
BIOCHEMICAL DIAGNOSTICS INC
18008247
In Commercial Distribution

  • 00810042682511 ()
18008247

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042682504

Menu CA, CUTOFF -50%
BIOCHEMICAL DIAGNOSTICS INC
18008246
In Commercial Distribution

  • 00810042682504 ()
18008246

  • Multiple drugs of abuse IVD, control

Astra Tech Implant System® - 07392532002496

Slot CA Driver Long
Dentsply Implants Manufacturing GmbH
22689
In Commercial Distribution

  • 07392532002496 ()
22689

  • Surgical screwdriver, reusable

Astra Tech Implant System® - 07392532002489

Slot CA Driver Short
Dentsply Implants Manufacturing GmbH
22688
In Commercial Distribution

  • 07392532002489 ()
22688

  • Surgical screwdriver, reusable

Curaplex - 00810071631122

CONN.TUBE,14'*,50/CA
BOUND TREE MEDICAL, LLC
301-142
In Commercial Distribution

  • 00810071630729 ()
  • 00810071631122 ()
301-142

  • Oxygen administration tubing

HARDIE - E23503900

CA HARDIE BLACK FL2
SHOFU DENTAL CORPORATION
0390
In Commercial Distribution

  • E23503900 ()
0390

  • Dental abrasive point, reusable

CA PORC LAMINATE KIT - E23503170

CA PORC LAMINATE KIT
SHOFU DENTAL CORPORATION
0317
In Commercial Distribution

  • E23503170 ()
0317

  • Dental abrasive point, reusable

COMPOSITE - E23503100

CA COMPOSITE POL KIT
SHOFU DENTAL CORPORATION
0310
In Commercial Distribution

  • E23503100 ()
0310

  • Dental abrasive point, reusable

CA AMALGAM POLISH KT - E23503080

CA AMALGAM POLISH KT
SHOFU DENTAL CORPORATION
0308
In Commercial Distribution

  • E23503080 ()
0308

  • Dental abrasive point, reusable

CA ENAMEL ADJ KIT - E23503070

CA ENAMEL ADJ KIT
SHOFU DENTAL CORPORATION
0307
In Commercial Distribution

  • E23503070 ()
0307

  • Dental abrasive point, reusable

COMPOSITE - E23502970

CA COMPOSITE-FINE POINT IC
SHOFU DENTAL CORPORATION
0297
In Commercial Distribution

  • E23502970 ()
0297

  • Dental abrasive point, reusable

CERAMISTE - E23502590

CA CERAMISTE UL2 WHEEL
SHOFU DENTAL CORPORATION
0259
In Commercial Distribution

  • E23502590 ()
0259

  • Dental abrasive point, reusable

CERAMISTE - E23502580

CA CERAMISTE UL2 KNIFE
SHOFU DENTAL CORPORATION
0258
In Commercial Distribution

  • E23502580 ()
0258

  • Dental abrasive point, reusable

CERAMISTE - E23502570

CA CERAMISTE UL2 BULLET
SHOFU DENTAL CORPORATION
0257
In Commercial Distribution

  • E23502570 ()
0257

  • Dental abrasive point, reusable

CERAMISTE - E23502560

CA CERAMISTE UL WHEEL
SHOFU DENTAL CORPORATION
0256
In Commercial Distribution

  • E23502560 ()
0256

  • Dental abrasive point, reusable

CERAMISTE - E23502550

CA CERAMISTE UL KNIFE
SHOFU DENTAL CORPORATION
0255
In Commercial Distribution

  • E23502550 ()
0255

  • Dental abrasive point, reusable

CERAMISTE - E23502540

CA CERAMISTE UL BULLET
SHOFU DENTAL CORPORATION
0254
In Commercial Distribution

  • E23502540 ()
0254

  • Dental abrasive point, reusable

CERAMISTE - E23502530

CA CERAMISTE STD WHEEL
SHOFU DENTAL CORPORATION
0253
In Commercial Distribution

  • E23502530 ()
0253

  • Dental abrasive point, reusable

CERAMISTE - E23502520

CA CERAMISTE STD KNIFE
SHOFU DENTAL CORPORATION
0252
In Commercial Distribution

  • E23502520 ()
0252

  • Dental abrasive point, reusable

CERAMISTE - E23502510

CA CERAMISTE STD BULLET
SHOFU DENTAL CORPORATION
0251
In Commercial Distribution

  • E23502510 ()
0251

  • Dental abrasive point, reusable

COMPOSITE - E23501980

CA COMPOSITE POINT MID-POINT
SHOFU DENTAL CORPORATION
0198
In Commercial Distribution

  • E23501980 ()
0198

  • Dental abrasive point, reusable

COMPOSITE - E23501970

CA COMPOSITE POINT IC
SHOFU DENTAL CORPORATION
0197
In Commercial Distribution

  • E23501970 ()
0197

  • Dental abrasive point, reusable

COMPOSITE - E23501960

CA COMPOSITE POINT PEAR-POINT
SHOFU DENTAL CORPORATION
0196
In Commercial Distribution

  • E23501960 ()
0196

  • Dental abrasive point, reusable

COMPOSITE - E23501950

CA COMPOSITE POINT CUP
SHOFU DENTAL CORPORATION
0195
In Commercial Distribution

  • E23501950 ()
0195

  • Dental abrasive point, reusable

COMPOSITE - E23501940

CA COMPOSITE POINT DISK
SHOFU DENTAL CORPORATION
0194
In Commercial Distribution

  • E23501940 ()
0194

  • Dental abrasive point, reusable

COMPOSITE - E23501930

CA COMPOSITE POINT WHEEL
SHOFU DENTAL CORPORATION
0193
In Commercial Distribution

  • E23501930 ()
0193

  • Dental abrasive point, reusable

COMPOSITE - E23501920

CA COMPOSITE POINT KNIFE
SHOFU DENTAL CORPORATION
0192
In Commercial Distribution

  • E23501920 ()
0192

  • Dental abrasive point, reusable

COMPOSITE - E23501910

CA COMPOSITE POINT BULLET
SHOFU DENTAL CORPORATION
0191
In Commercial Distribution

  • E23501910 ()
0191

  • Dental abrasive point, reusable

CERAMISTE - E235256A0

CA CERAMISTE UL MP
SHOFU DENTAL CORPORATION
256A
In Commercial Distribution

  • E235256A0 ()
256A

  • Dental abrasive point, reusable

CERAMISTE - E235254A0

CA CERAMISTE UL CUP
SHOFU DENTAL CORPORATION
254A
In Commercial Distribution

  • E235254A0 ()
254A

  • Dental abrasive point, reusable

CERAMISTE - E235251A0

CA CERAMISTE STD CUP
SHOFU DENTAL CORPORATION
251A
In Commercial Distribution

  • E235251A0 ()
251A

  • Dental abrasive point, reusable

CERAMASTER - E235125C0

CERAMASTER CRS ASSORTED CA
SHOFU DENTAL CORPORATION
125C
In Commercial Distribution

  • E235125C0 ()
125C

  • Dental abrasive point, reusable

CERAMASTER - E235124C0

CERAMASTER CRS CA MINI
SHOFU DENTAL CORPORATION
124C
In Commercial Distribution

  • E235124C0 ()
124C

  • Dental abrasive point, reusable

CERAMASTER - E235123C0

CERAMASTER CRS CA CUP
SHOFU DENTAL CORPORATION
123C
In Commercial Distribution

  • E235123C0 ()
123C

  • Dental abrasive point, reusable

CERAMASTER - E235122C0

CERAMASTER CRS CA KNIFE
SHOFU DENTAL CORPORATION
122C
In Commercial Distribution

  • E235122C0 ()
122C

  • Dental abrasive point, reusable

CERAMASTER - E235121C0

CERAMASTER CRS CA BULLET
SHOFU DENTAL CORPORATION
121C
In Commercial Distribution

  • E235121C0 ()
121C

  • Dental abrasive point, reusable

COMPOMASTER - E235115C0

COMPOMASTER CRS ASSORTED CA
SHOFU DENTAL CORPORATION
115C
In Commercial Distribution

  • E235115C0 ()
115C

  • Dental abrasive point, reusable

COMPOMASTER - E235114C0

COMPOMASTER CRS CA MINI
SHOFU DENTAL CORPORATION
114C
In Commercial Distribution

  • E235114C0 ()
114C

  • Dental abrasive point, reusable

COMPOMASTER - E235113C0

COMPOMASTER CRS CA CUP
SHOFU DENTAL CORPORATION
113C
In Commercial Distribution

  • E235113C0 ()
113C

  • Dental abrasive point, reusable

COMPOMASTER - E235112C0

COMPOMASTER CRS CA KNIFE
SHOFU DENTAL CORPORATION
112C
In Commercial Distribution

  • E235112C0 ()
112C

  • Dental abrasive point, reusable

COMPOMASTER - E235111C0

COMPOMASTER CRS CA BULLET
SHOFU DENTAL CORPORATION
111C
In Commercial Distribution

  • E235111C0 ()
111C

  • Dental abrasive point, reusable

ZILMASTER - E23506810

ZILMASTER ADJUSTMENT KIT CA
SHOFU DENTAL CORPORATION
681
In Commercial Distribution

  • E23506810 ()
681

  • Dental abrasive point, reusable

CERAMISTE - E235259A0

CA CERAMISTE UL2 MP
SHOFU DENTAL CORPORATION
259A
In Commercial Distribution

  • E235259A0 ()
259A

  • Dental abrasive point, reusable

CERAMISTE - E235257A0

CA CERAMISTE UL2 CUP
SHOFU DENTAL CORPORATION
257A
In Commercial Distribution

  • E235257A0 ()
257A

  • Dental abrasive point, reusable

Medline Industries, Inc. - 10198459187674

SYR, CA, TACE KIT
MEDLINE INDUSTRIES, INC.
VASC1643
In Commercial Distribution

  • 40198459187675 ()
  • 10198459187674 ()
VASC1643

  • General surgical procedure kit, non-medicated, single-use

Articulator - E1997592331

Articulator CA 3.0 LARGE
Candulor AG
759233
In Commercial Distribution

  • E1997592331 ()
759233

  • Dental articulator

JOBST Custom Seamless Soft - 04019702244878

O3/AG/OT/CA
BSN-Jobst GmbH
73553-00000-00
In Commercial Distribution

  • 04019702244878 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

Medline Industries, Inc. - 10195327631697

LHK, CA, SOUTHLAKE REGIONAL
MEDLINE INDUSTRIES, INC.
VASC1498
In Commercial Distribution

  • 40195327631698 ()
  • 10195327631697 ()
VASC1498

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327616076

PROVIDENCE CA MINOR PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ35372L
In Commercial Distribution

  • 40195327616077 ()
  • 10195327616076 ()
DYNJ35372L

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327616052

PROVIDENCE CA LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ35090K
In Commercial Distribution

  • 40195327616053 ()
  • 10195327616052 ()
DYNJ35090K

  • General surgical procedure kit, non-medicated, single-use
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