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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T1IC - Instrument (Kit) Carry Case
RADLEY SCIENTIFIC LIMITED
Series 1
In Commercial Distribution

  • 05060634770118 ()
T1IC

  • Hard/soft-tissue ultrasonic surgical system
T1GC - Generator (Kit) Carry Case
RADLEY SCIENTIFIC LIMITED
Series 1
In Commercial Distribution

  • 05060634770040 ()
T1GC

  • Hard/soft-tissue ultrasonic surgical system
Remedy Stemmed Knee Spacer Case
OSTEOREMEDIES, LLC
RSKBASE
In Commercial Distribution

  • 00850011453216 ()
RSKBASE

  • Instrument tray, reusable
Sterilisation Case - Inner Layer (3)
AXIS SPINE TECHNOLOGIES LTD
2984 40 610
In Commercial Distribution

  • 05056619801434 ()
2984 40 610

  • Device sterilization/disinfection container, reusable
X-PAC Lateral Instrument Case 2
EXPANDING INNOVATIONS, INC.
EI3019
In Commercial Distribution

  • 00850001720618 ()


  • Instrument tray, reusable
X-PAC Lateral Instrument Case 1
EXPANDING INNOVATIONS, INC.
EI3018
In Commercial Distribution

  • 00850001720601 ()


  • Instrument tray, reusable
LifeBubble Evaluation Kit (30/case)
NOVONATE INC
LEK
In Commercial Distribution

  • 00850002447316 ()
  • 00850002447248 ()
LEK

  • Wearable percutaneous catheter/tube holder
Adhesive Pack, Small (20/Case)
NOVONATE INC
AP20-S
In Commercial Distribution

  • 00850002447149 ()
  • 00850002447118 ()

  • Catheter Gauge: 5 French
  • Catheter Gauge: 3.5 French
AP20-S

  • Wearable percutaneous catheter/tube holder
LifeBubble Kit, Small (20/Case)
NOVONATE INC
LK20-S
In Commercial Distribution

  • 00850002447125 ()
  • 00850002447095 ()

  • Catheter Gauge: 5 French
  • Catheter Gauge: 3.5 French
LK20-S

  • Wearable percutaneous catheter/tube holder
CASE EA520 INSTRUMENT HT HANDPIECE
MEDTRONIC POWERED SURGICAL SOLUTIONS
EA520
In Commercial Distribution

  • 00643169080911 ()


  • Instrument tray, reusable
Fiberglass Tape Measure (White Case)
BV Medical
80-380-000
In Commercial Distribution

  • 00845821031341 ()
  • 00845821011138 ()


  • Tape measure, reusable
Fortilink-L IBF System Instrument Case
Pioneer Surgical Technology, Inc.
65-L-Case
Not in Commercial Distribution

  • 00846468086510 ()
65-L-Case

  • Device sterilization/disinfection container, reusable
CASE 7574040L LONGITUDE TRAUMA LID
MEDTRONIC SOFAMOR DANEK, INC.
7574040L
In Commercial Distribution

  • 00613994912060 ()


  • Instrument tray, reusable
Bear SET with Carrying case
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430426 ()
RDA2132BA

  • Automated ophthalmic refractometer
Fireworks SET with Carrying case
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430372 ()
RDA2142BA

  • Automated ophthalmic refractometer
CASE 2990006 CAPSTONE TRAY 2
MEDTRONIC SOFAMOR DANEK, INC.
2990006
In Commercial Distribution

  • 00613994805911 ()


  • Instrument tray, reusable
CASE 2990005 CAPSTONE TRAY 1
MEDTRONIC SOFAMOR DANEK, INC.
2990005
In Commercial Distribution

  • 00613994805904 ()


  • Instrument tray, reusable
INITIA INTERMEDIATE SIZE BROACH CASE
KYOCERA CORPORATION
21057-00-0000
In Commercial Distribution

  • 04547898433979 ()
21057-00-0000

  • Joint prosthesis implantation kit, reusable
OsteoPower Carrying Case with Rollers
OSTEOMED LLC
450-0550
In Commercial Distribution

  • 00845694037204 ()
450-0550

  • General internal orthopaedic fixation system implantation kit
ExtremiLOCK Ankle Fracture Tray Case
OSTEOMED LLC
320-2920
In Commercial Distribution

  • 00845694049559 ()
320-2920

  • General internal orthopaedic fixation system implantation kit
U2 Knee AiO femur case
UNITED ORTHOPEDIC CORP.
9304-8110
In Commercial Distribution

  • 04719872178125 ()
9304-8110

  • Instrument tray, reusable
U2 Knee size 7 case
UNITED ORTHOPEDIC CORP.
9303-8070
In Commercial Distribution

  • 04719872178026 ()
9303-8070

  • Instrument tray, reusable
U2 Revision hip trial case
UNITED ORTHOPEDIC CORP.
9104-8050-RT
In Commercial Distribution

  • 04719872177715 ()
9104-8050-RT

  • Instrument tray, reusable
U2 Revision hip stem case
UNITED ORTHOPEDIC CORP.
9104-8040-RT
In Commercial Distribution

  • 04719872177708 ()
9104-8040-RT

  • Instrument tray, reusable
CLINICAL EVALUATION CASE, STREAMLINE TL-DEGEN
Pioneer Surgical Technology, Inc.
408-867
Not in Commercial Distribution

  • 00846468041281 ()
408-867

  • Device sterilization/disinfection container, reusable
Recipient Base Mold; 3/case
SAKURA FINETEK U.S.A., INC.
8020
In Commercial Distribution

  • 00615233081834 ()
8020

  • Tissue embedding mould IVD, reusable
UTF Stem, reduced, case #1
UNITED ORTHOPEDIC CORP.
9106-8310-RD
In Commercial Distribution

  • 04711605584517 ()
9106-8310-RD

  • Instrument tray, reusable
CERVICAL IMPLANT AND INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
20-PAC-SYSTEM
Not in Commercial Distribution

  • 00846468024741 ()
20-PAC-SYSTEM

  • General internal orthopaedic fixation system implantation kit
7.5MM CANNULATED SCREW CASE BASE
Pioneer Surgical Technology, Inc.
00-1147-077-01
In Commercial Distribution

  • 00846468074449 ()
00-1147-077-01

  • Device sterilization/disinfection container, reusable
Sterilization Case, Calix, TLIF Trials
Xtant Medical Holdings, Inc.
X034-2231
In Commercial Distribution

  • M697X03422310 ()
  • M697X03422311 ()


  • Polymeric spinal interbody fusion cage
Sterilization Case, Calix, PLIF Trials
Xtant Medical Holdings, Inc.
X034-2221
In Commercial Distribution

  • M697X03422210 ()
  • M697X03422211 ()


  • Polymeric spinal interbody fusion cage
Sterilization Case, Calix, Disc Preparation
Xtant Medical Holdings, Inc.
X034-2203
In Commercial Distribution

  • M697X03422030 ()
  • M697X03422031 ()


  • Polymeric spinal interbody fusion cage
Sterilization Case II, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0005
In Commercial Distribution

  • M697X07300050 ()
  • M697X07300051 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case I, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0004
In Commercial Distribution

  • M697X07300040 ()
  • M697X07300041 ()


  • Device sterilization/disinfection container, reusable
STERILIZATION CASE, ADDITIONAL INSTRUMENTS, IRIX-C
Xtant Medical Holdings, Inc.
X066-0006
In Commercial Distribution

  • M697X06600060 ()
  • M697X06600061 ()


  • Polymeric spinal interbody fusion cage
Sidestream, Disposable, Case of 200.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
Not in Commercial Distribution

  • 00383730001517 ()
4445A

  • Benchtop nebulizer, non-heated
SideStream Dispoable, Case of 50
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730001500 ()
4445

  • Benchtop nebulizer, non-heated
SideStream Durable, Case of 50.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730001067 ()
1201

  • Benchtop nebulizer, non-heated
Sterilization Case I, Atrix-C, Instruments
Xtant Medical Holdings, Inc.
X094-0003
In Commercial Distribution

  • M697X09400030 ()
  • M697X09400031 ()


  • Cadaveric-donor bone allograft
Irix A Sterlization Case, Secondary
Xtant Medical Holdings, Inc.
X080-0006
In Commercial Distribution

  • M697X08000060 ()
  • M697X08000061 ()


  • Instrument tray, reusable
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