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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RAPIDLOC MENISCAL REPAIR-PLA TOPHAT / 12 Degrees Absorbable - PLA/PLA with Size 2/0 (3 metric) ETHIBOND Green braided polyester suture, and 12 Degrees curved needle
DEPUY MITEK, LLC
228421
Not in Commercial Distribution

  • 10886705010257 ()
228421

  • Tendon/ligament bone anchor, bioabsorbable
RAPIDLOC MENISCAL REPAIR-PLA TOPHAT / 27 Degrees Absorbable - PLA/PLA with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 27 Degrees curved needle
DEPUY MITEK, LLC
228322
Not in Commercial Distribution

  • 10886705010233 ()
228322

  • Tendon/ligament bone anchor, bioabsorbable
RAPIDLOC MENISCAL REPAIR-PLA TOPHAT / 0 Degrees Absorbable - PLA/PLA with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and straight needle
DEPUY MITEK, LLC
228320
Not in Commercial Distribution

  • 10886705010219 ()
228320

  • Tendon/ligament bone anchor, bioabsorbable
RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 27 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 27 Degrees curved needle
DEPUY MITEK, LLC
228312
Not in Commercial Distribution

  • 10886705010202 ()
228312

  • Tendon/ligament bone anchor, bioabsorbable
RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) each Sleeve Assemblies, (1) each Interlocking Trocar, (1) Pusher Rod, and (1) Bone Gauge Pin
DEPUY MITEK, LLC
213015
In Commercial Distribution

  • 20886705020017 ()
213015

  • Tendon/ligament bone anchor, non-bioabsorbable
RIGIDFIX CURVE ST ACL PLA Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm Poly Lactic Acid (PLA), (2) each Sleeve Assemblies, (1) each Interlocking Trocar, (1) Pusher Rod, and (1) Bone Gauge Pin
Medos International Sàrl
213013
In Commercial Distribution

  • 20886705020000 ()
213013

  • Tendon/ligament bone anchor, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
52-306-25-04
In Commercial Distribution

  • 00888118000583 ()

  • 26 X 26 MM, T=0.6MM


  • Craniofacial fixation plate, bioabsorbable
The Evolution ALUS Unload Table, (26 x 26 x 61-inch) is used with the HC-1000 Evolution Steam Sterilizer.
Steris Mexico, S. de R.L. de C.V.
15090-14
In Commercial Distribution

  • 07350109400212 ()
01509014

  • Sterilizer/disinfector rack
The Evolution ALUS Load Table, (26 x 26 x 61-inch) is used with the HC-1000 Evolution Steam Sterilizer.
Steris Mexico, S. de R.L. de C.V.
15090-04
In Commercial Distribution

  • 07350109400205 ()
01509004

  • Sterilizer/disinfector rack
The Evolution ALUS Unload Table, (26 x 26 x 49-inch) is used with HC-800 the Evolution Steam Sterilizer.
Steris Mexico, S. de R.L. de C.V.
15090-13
In Commercial Distribution

  • 07350109400199 ()
01509013

  • Sterilizer/disinfector rack
The Evolution ALUS Load Table, (26 x 26 x 49-inch) is used with the HC-800 Evolution Steam Sterilizer.
Steris Mexico, S. de R.L. de C.V.
15090-03
In Commercial Distribution

  • 07350109400182 ()
01509003

  • Sterilizer/disinfector rack
The Evolution ALUS Unload Table, (26 x 26 x 39-inch) is used with HC-600 the Evolution Steam Sterilizer.
Steris Mexico, S. de R.L. de C.V.
15090-12
In Commercial Distribution

  • 07350109400175 ()
01509012

  • Sterilizer/disinfector rack
The Evolution ALUS Load Table, (26 x 26 x 39-inch) is used with the HC-600 Evolution Steam Sterilizer.
Steris Mexico, S. de R.L. de C.V.
15090-02
In Commercial Distribution

  • 07350109400168 ()
01509002

  • Sterilizer/disinfector rack
LeadCare® Blood Lead Control Kit
MAGELLAN DIAGNOSTICS, INC.
LeadCare®
In Commercial Distribution

  • 00850355006161 ()
70-3440

  • Lead (Pb) analyser IVD
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
AUTOMATED OPHTHALMICS, INC.
AO316
In Commercial Distribution

  • 00860000603805 ()


  • Ophthalmic tonometer tip cover
FreeStyle Control Solution
ABBOTT DIABETES CARE INC
70432
In Commercial Distribution

  • 20699073704324 ()
  • 00699073704320 ()
70432

  • Glucose monitoring system IVD, home-use
FreeStyle Control Solution
ABBOTT DIABETES CARE INC
14002
In Commercial Distribution

  • 20699073140023 ()
  • 00699073140029 ()
  • 10699073140026 ()
14002

  • Glucose monitoring system IVD, home-use
Skin Surface Temperature Probe Reusable; stainless steel disc; epoxy backing; size = 3/8" (9.5mm); length = 10' (3.1m); wgt = 1 lb (454g)
Philips Medical Systems Hsg
Skin Surface Temperature Probe
Not in Commercial Distribution

  • 00884838001015 ()
21078A

  • General-purpose patient temperature probe, reusable
Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size 10Fr; probe length = 10' (3.1m); wgt = 1 lb (454g)
Philips Medical Systems Hsg
Esophageal/Rectal Temperature Probe
Not in Commercial Distribution

  • 00884838001008 ()
21076A

  • General-purpose patient temperature probe, reusable
Esophageal/Rectal Temperature Probe Reusable; vinyl tip end lead; size = 15 Fr; probe length = 10' (3.1m); wgt = l lb (454g)
Philips Medical Systems Hsg
Esophageal/Rectal Temperature Probe
Not in Commercial Distribution

  • 00884838000995 ()
21075A

  • General-purpose patient temperature probe, reusable
No-Mix Orthodontic Adhesive (Primer-Activated) Mini Kit
ORTHO ORGANIZERS, INC.
490-350
Not in Commercial Distribution

  • 00190707000325 ()


  • Orthodontic bracket adhesive
No-Mix Adhesive Syringe
ORTHO ORGANIZERS, INC.
490-114
Not in Commercial Distribution

  • 00190707000141 ()


  • Orthodontic bracket adhesive
Control Module MR Interlock System- DIRECT MARK
DEVICOR MEDICAL PRODUCTS, INC.
MRLB1
In Commercial Distribution

  • 00841911101888 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Holster and Cable
DEVICOR MEDICAL PRODUCTS, INC.
STCH1
In Commercial Distribution

  • 00841911101840 ()


  • Mammographic stereotactic biopsy system
Cart
DEVICOR MEDICAL PRODUCTS, INC.
SCMC1
In Commercial Distribution

  • 00841911101819 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Coag-Sense PT/INR Patient Self-Test System
COAGUSENSE INC.
200221
In Commercial Distribution

  • 00861900000381 ()
03P70-01

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense PT/INR Professional System
COAGUSENSE INC.
200222
In Commercial Distribution

  • 00861900000374 ()
03P70-02

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense PT/INR Meter
COAGUSENSE INC.
200107
In Commercial Distribution

  • 00861900000350 ()
03P73-01

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense Professional Control Test Strip Kit - 10 Ct
COAGUSENSE INC.
100250
In Commercial Distribution

  • 00861900000343 ()
03P69-10

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Coag-Sense Test Strip Kit - 50 Ct
COAGUSENSE INC.
100218
In Commercial Distribution

  • 00861900000336 ()
03P56-50

  • Prothrombin time (PT) IVD, kit, rapid clotting, clinical
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0724
In Commercial Distribution

  • 10811503033528 ()
NP377SS0724

  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0726
In Commercial Distribution

  • 10811503033511 ()
NP377SS0726

  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0724
In Commercial Distribution

  • 10811503033481 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0726
In Commercial Distribution

  • 10811503033474 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SP0728
In Commercial Distribution

  • 10811503033436 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377EO0828
In Commercial Distribution

  • 10811503033429 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377ER0830
In Commercial Distribution

  • 10811503033412 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377EO0826
In Commercial Distribution

  • 10811503033405 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SL7526
In Commercial Distribution

  • 10811503033399 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331TP0724
In Commercial Distribution

  • 10811503033382 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP330SP0626
In Commercial Distribution

  • 10811503033375 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331TP0726
In Commercial Distribution

  • 10811503033368 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP376SJ0728
In Commercial Distribution

  • 10811503033337 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP376SJ0726
In Commercial Distribution

  • 10811503033320 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SP0726
In Commercial Distribution

  • 10811503033313 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331SP0724
In Commercial Distribution

  • 10811503033306 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331SH0726
In Commercial Distribution

  • 10811503033276 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP331SH0724
In Commercial Distribution

  • 10811503033269 ()


  • Polymeric ureteral stent
Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SH0726
In Commercial Distribution

  • 10811503033252 ()


  • Polymeric ureteral stent
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