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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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Xpress Minimally Invasive Pedicle Screw System - M697X07300051

Sterilization Case II, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0005
In Commercial Distribution

  • M697X07300050 ()
  • M697X07300051 ()


  • Device sterilization/disinfection container, reusable

Xpress Minimally Invasive Pedicle Screw System - M697X07300041

Sterilization Case I, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0004
In Commercial Distribution

  • M697X07300040 ()
  • M697X07300041 ()


  • Device sterilization/disinfection container, reusable

Irix-C Cervical Integrated Fusion System - M697X06600061

STERILIZATION CASE, ADDITIONAL INSTRUMENTS, IRIX-C
Xtant Medical Holdings, Inc.
X066-0006
In Commercial Distribution

  • M697X06600060 ()
  • M697X06600061 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03422311

Sterilization Case, Calix, TLIF Trials
Xtant Medical Holdings, Inc.
X034-2231
In Commercial Distribution

  • M697X03422310 ()
  • M697X03422311 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03422211

Sterilization Case, Calix, PLIF Trials
Xtant Medical Holdings, Inc.
X034-2221
In Commercial Distribution

  • M697X03422210 ()
  • M697X03422211 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03422031

Sterilization Case, Calix, Disc Preparation
Xtant Medical Holdings, Inc.
X034-2203
In Commercial Distribution

  • M697X03422030 ()
  • M697X03422031 ()


  • Polymeric spinal interbody fusion cage

Wound Seal Kit - M689HHWSK01040

Wound Seal Kit, 25/Case
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M689HHWSK01040 ()
HHWSK01

  • Pneumothorax dressing

H&H Simplified Cric Kit - M689HHSCK01020

Simplified Cricothyrotomy Kit, 10/Case
Safeguard US Operating, LLC
02
In Commercial Distribution

  • M689HHSCK01020 ()
HHSCK01

  • Cricothyrotome, single-use

Sidestream - 00383730001517

Sidestream, Disposable, Case of 200.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
Not in Commercial Distribution

  • 00383730001517 ()
4445A

  • Benchtop nebulizer, non-heated

SIDESTREAM - 00383730001500

SideStream Dispoable, Case of 50
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730001500 ()
4445

  • Benchtop nebulizer, non-heated

SideStream - 00383730001067

SideStream Durable, Case of 50.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730001067 ()
1201

  • Benchtop nebulizer, non-heated

X90 Pedicle Screw System - M697N600022011

Sterilization Case, 5.5mm Rod, Instrument
Xtant Medical Holdings, Inc.
N60002201
In Commercial Distribution

  • M697N600022010 ()
  • M697N600022011 ()


  • Device sterilization/disinfection container, reusable

Fortex Pedicle Screw System - M697X02201971

Sterilization Case II, Fortex, Instrument
Xtant Medical Holdings, Inc.
X022-0197
In Commercial Distribution

  • M697X02201970 ()
  • M697X02201971 ()


  • Device sterilization/disinfection container, reusable

Fortex Pedicle Screw System - M697X02201961

Sterilization Case II, Fortex, Implant
Xtant Medical Holdings, Inc.
X022-0196
In Commercial Distribution

  • M697X02201960 ()
  • M697X02201961 ()


  • Device sterilization/disinfection container, reusable

OIC Variable Angle Small Fragment Locking Plate System - M696DR0010

STERILIZATION CASE DRILL BIT CADDY
ORTHOPAEDIC IMPLANT COMPANY, THE
DR-001
In Commercial Distribution

  • M696DR0010 ()


  • Device sterilization/disinfection container, reusable

C-PS Peek Optima Cervical Interbody Spacer - M696CPS600S0

STERILIZATION CASE CERVICAL CAGE SET
ORTHOPAEDIC IMPLANT COMPANY, THE
CPS-600S
In Commercial Distribution

  • M696CPS600S0 ()


  • Device sterilization/disinfection container, reusable

OIC Variable Angle Small Fragment Locking Plate System - M69601PRXTIB010

STERILIZATION CASE PROX TIB PLATES
ORTHOPAEDIC IMPLANT COMPANY, THE
01-PRXTIB01
In Commercial Distribution

  • M69601PRXTIB010 ()


  • Device sterilization/disinfection container, reusable

OIC Variable Angle Small Fragment Locking Plate System - M69601PHP040

STERILIZATION CASE PROXIMAL PLATE COMPLETE
ORTHOPAEDIC IMPLANT COMPANY, THE
01-PHP04
In Commercial Distribution

  • M69601PHP040 ()


  • Device sterilization/disinfection container, reusable

C-PS Peek Optima Cervical Interbody Spacer - M69601CPS020

STERILIZATION CASE CERVICAL SPACER COMPLETE
ORTHOPAEDIC IMPLANT COMPANY, THE
01-CPS02
In Commercial Distribution

  • M69601CPS020 ()


  • Device sterilization/disinfection container, reusable

OIC Variable Angle Small Fragment Locking Plate System - M69601CP020

STERILIZATION CASE CLAVICLE PLATES COMPLETE
ORTHOPAEDIC IMPLANT COMPANY, THE
01-CP02
In Commercial Distribution

  • M69601CP020 ()


  • Device sterilization/disinfection container, reusable

OIC Variable Angle Small Fragment Locking Plate System - M696014150

STERILIZATION CASE UNIVERSAL OUTER MINI
ORTHOPAEDIC IMPLANT COMPANY, THE
01-415
In Commercial Distribution

  • M696014150 ()


  • Device sterilization/disinfection container, reusable

C-PS Peek Optima Cervical Interbody Spacer - M69601CPS010

STERILIZATION CASE CERVICAL SPACER INNER
ORTHOPAEDIC IMPLANT COMPANY, THE
01-CPS01
In Commercial Distribution

  • M69601CPS010 ()


  • Device sterilization/disinfection container, reusable

OIC Variable Angle Small Fragment Locking Plate System - M69601CP010

STERILIZATION CASE CLAVICLE PLATES INNER
ORTHOPAEDIC IMPLANT COMPANY, THE
01-CP01
In Commercial Distribution

  • M69601CP010 ()


  • Device sterilization/disinfection container, reusable

OIC Cannulated Screw System - M6960173120

STERILIZATION CASE LARGE CANNULATED SCREWS
ORTHOPAEDIC IMPLANT COMPANY, THE
01-7312
In Commercial Distribution

  • M6960173120 ()


  • Device sterilization/disinfection container, reusable

Prism Lens Case S, coated - 04049584001153

Prism Lens Case S, coated
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
33116
In Commercial Distribution

  • 04049584001153 ()


  • Trial lens frame

Ophthalmic Knife - 00841668101407

CASE FOR TWO MICROMETER HANDLES
KATENA PRODUCTS, INC.
K2-6556
In Commercial Distribution

  • 00841668101407 ()
K2-6556

  • Instrument tray, reusable

Ophthalmic Knife - 00841668101391

CASE FOR ONE MICROMETER HANDLE
KATENA PRODUCTS, INC.
K2-6555
In Commercial Distribution

  • 00841668101391 ()
K2-6555

  • Instrument tray, reusable

ASTRA Spine System - 00193082154485

ASTRA Degenerative Instruments Case 2
SPINECRAFT, LLC
6300-102B
In Commercial Distribution

  • 00193082154485 ()
6300-102B

  • General internal orthopaedic fixation system implantation kit

ASTRA Spine System - 00193082154454

ASTRA Degenerative Instruments Case 1
SPINECRAFT, LLC
6300-101B
In Commercial Distribution

  • 00193082154454 ()
6300-101B

  • General internal orthopaedic fixation system implantation kit

CARDINAL HEALTH - 10887488645025

STERILE LARGE CASE CUSTOM PACK
Cardinal Health 200, LLC
SBA63LCSE2
In Commercial Distribution

  • 50887488645023 ()
  • 10887488645025 ()
SBA63LCSE2

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

Armada - 00195377025937

Armada Ti Case, Long Instruments
Nuvasive, Inc.
7559309
In Commercial Distribution

  • 00195377025937 ()


  • Device sterilization/disinfection container, reusable

NA - 10886982183552

HYBRID FIXATOR SET GRAPHIC CASE
SYNTHES (U.S.A.) LP
304.340
Not in Commercial Distribution

  • 07611819706316 ()
  • H6793043400 ()
  • 10886982183552 ()
304340

  • Surgical instrument/implant rack

NA - 10886982185297

PELVIC IMPLANT SET GRAPHIC CASE
SYNTHES (U.S.A.) LP
306.10
Not in Commercial Distribution

  • H679306100 ()
  • 10886982185297 ()
30610

  • Surgical instrument/implant rack

NA - 10886982185242

PELVIC INSTRUMENT SET GRAPHIC CASE
Synthes GmbH
306.00
In Commercial Distribution

  • H679306000 ()
  • 10886982185242 ()
30600

  • Surgical instrument/implant rack

NA - 10886982185174

MEDIUM DISTRACTOR SET GRAPHIC CASE
Synthes GmbH
305.79
In Commercial Distribution

  • H679305790 ()
  • 10886982185174 ()
30579

  • Surgical instrument/implant rack

NA - 10886982185167

LARGE DISTRACTOR SET GRAPHIC CASE
Synthes GmbH
305.78
In Commercial Distribution

  • H679305780 ()
  • 10886982185167 ()
30578

  • Surgical instrument/implant rack

NA - 10886982185143

BONE FORCEPS SET GRAPHIC CASE
Synthes GmbH
305.75
In Commercial Distribution

  • H679305750 ()
  • 10886982185143 ()
30575

  • Surgical instrument/implant rack

NA - 10886982184702

BASIC SCREW SET CASE LID
SYNTHES (U.S.A.) LP
305.12
Not in Commercial Distribution

  • H679305120 ()
  • 10886982184702 ()
30512

  • Surgical instrument/implant rack

NA - 10886982184696

BASIC SCREW SET CASE BOTTOM
SYNTHES (U.S.A.) LP
305.11
Not in Commercial Distribution

  • H679305110 ()
  • 10886982184696 ()
30511

  • Surgical instrument/implant rack

NA - 10886982184641

BASIC SCREW SET GRAPHIC CASE
Synthes GmbH
305.10
In Commercial Distribution

  • H679305100 ()
  • 10886982184641 ()
30510

  • Surgical instrument/implant rack

NA - 10886982184566

1.0MM/1.3MM HAND MODULE CASE
Synthes GmbH
305.085
In Commercial Distribution

  • H6793050850 ()
  • 10886982184566 ()
305085

  • Surgical instrument/implant rack

NA - 10886982184481

3.5MM/4.0MM FOOT MODULE CASE
Synthes GmbH
305.068
In Commercial Distribution

  • 07611819758179 ()
  • H6793050680 ()
  • 10886982184481 ()
305068

  • Surgical instrument/implant rack

NA - 10886982184382

2.4MM TI HAND MODULE CASE
Synthes GmbH
304.579
In Commercial Distribution

  • 07611819707962 ()
  • H6793045790 ()
  • 10886982184382 ()
304579

  • Surgical instrument/implant rack

NA - 10886982184375

2.0MM TI HAND MODULE CASE
Synthes GmbH
304.578
In Commercial Distribution

  • 07611819707955 ()
  • H6793045780 ()
  • 10886982184375 ()
304578

  • Surgical instrument/implant rack

NA - 10886982184368

1.5MM TI HAND MODULE CASE
Synthes GmbH
304.577
In Commercial Distribution

  • 07611819707948 ()
  • H6793045770 ()
  • 10886982184368 ()
304577

  • Surgical instrument/implant rack

Novation - 10885862141743

INSTRUMENT CASE, NOVATION A+, RETRACTOR
Exactech, Inc.
167-32-02
In Commercial Distribution

  • 10885862141743 ()
167-32-02

  • Instrument tray, reusable

Novation - 10885862141729

INSTRUMENT CASE, NOVATION CFS, BROACH
Exactech, Inc.
169-33-02
In Commercial Distribution

  • 10885862141729 ()
169-33-02

  • Instrument tray, reusable

ARKANSAS HARD SHARPENER - 00192896090606

ARKANSAS HARD SHARPENER IN CASE
SONTEC INSTRUMENTS, INC.
1100-5821
Not in Commercial Distribution

  • 00192896090606 ()
1100-5821

  • Orthopaedic bone pin sharpener

Novation - 10885862199546

NOVATION LINER TRIAL CASE ASSEMBLY
Exactech, Inc.
141-47-00
In Commercial Distribution

  • 10885862199546 ()
141-47-00

  • Instrument tray, reusable

LATARJET EXPERIENCE - 10886705026951

Latarjet EXPERIENCE Latarjet Case Lid
Medos International Sàrl
288217
In Commercial Distribution

  • 10886705026951 ()
288217

  • Instrument tray, reusable
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