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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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Hallu®- LOCK - 10381780051459

Large quick coupling system with AO attachment.
NEWDEAL
997100ND
Not in Commercial Distribution

  • M248997100ND1 ()
  • 10381780051459 ()


  • Surgical instrument handle, non-torque-limiting

Signature - B3315851034

Dolphin Nose Dissecting Forceps With Tissue Well
SILEX MEDICAL, LLC
5851034
In Commercial Distribution

  • B3315851034 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Rigid endoscopic tissue manipulation forceps, reusable

Actiwave - B329AWVC23

Ambulatory ECG recorder with accelerometer - single channel
CAMNTECH LIMITED
Cardio
Not in Commercial Distribution

  • B329AWVC23 ()
08-603

  • Telemetric electrocardiographic ambulatory recorder

Actiheart - B329AHBT56

Ambulatory ECG recorder with acclerometer - single channel
CAMNTECH LIMITED
AH5 BT
In Commercial Distribution

  • B329AHBT56 ()
18-505

  • Telemetric electrocardiographic ambulatory recorder

Actiheart - B329AH556

Ambulatory ECG recorder with acclerometer - single channel
CAMNTECH LIMITED
AH5
In Commercial Distribution

  • B329AH556 ()
18-500

  • Telemetric electrocardiographic ambulatory recorder

Actiheart - B329AH420

Ambulatory ECG recorder with acclerometer - single channel
CAMNTECH LIMITED
AH4
Not in Commercial Distribution

  • B329AH420 ()
08-305

  • Telemetric electrocardiographic ambulatory recorder

C.M.P. Cable - B312AD46020

Alternate Banana Adapter (with Allen Key wrench)
C.M.P. Canadian Medical Products Inc
AD4602
In Commercial Distribution

  • B312AD46020 ()


  • Transcutaneous electrical stimulation lead

Integra® - 10381780072348

Integra® Pudenz Ventricular Catheter with Stylet
Integra Lifesciences Corporation
NL8501504
In Commercial Distribution

  • 10381780072348 ()
  • M269NL85015041 ()

  • Tubing: 1.3mm I.D. x 2.2mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NL8501504

  • Intracerebral infusion/drainage catheter, long-term

Integra® - 10381780071686

Integra® EVD System with Burette Sampling
Integra Lifesciences Corporation
NL8508502
In Commercial Distribution

  • 10381780071686 ()
  • M269NL85085021 ()

  • 50ml vented burette, 200cm plastic tubing
NL8508502

  • Ventricular cerebrospinal fluid drainage catheterization kit

NA - B34025189990

No. 4 pad with wings bulk packed
IMPACT PRODUCTS, LLC
25189990
In Commercial Distribution

  • B34025189990 ()
25189990

  • Menstrual pad, unscented
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