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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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Titan™ - 10381780246527

Titan™ Total Shoulder System The osteotome is an instrument used for cutting bone in conjunction with the Titan Total Shoulder System.
Ascension Orthopedics, Inc.
OST-0940-045-502
Not in Commercial Distribution

  • M269OST09400455021 ()
  • 10381780246527 ()

  • 8.57 in L x .710 in dia head
OST-0940-045-502

  • Orthopaedic osteotome blade, reusable

Movement® - 10381780245797

Movement® Great Toe System Proximal Phalanx Impactor The Proximal Phalanx Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IMP-890-00PP
In Commercial Distribution

  • M269IMP89000PP1 ()
  • 10381780245797 ()

  • 6.0 in L x .60 in dia tip
IMP-890-00PP

  • Orthopaedic implant impactor, reusable

Movement® - 10381780245780

Movement® Great Toe System Metatarsal Impactor The Metatarsal Impactor is used to properly fit the implant and/or trial into the prepared cavity.
Ascension Orthopedics, Inc.
IMP-890-00MT
In Commercial Distribution

  • M269IMP89000MT1 ()
  • 10381780245780 ()

  • 5.98 in L x .60 in dia tip
IMP-890-00MT

  • Orthopaedic implant impactor, reusable

Titan™ - 10381780245315

Titan™ Total Shoulder System Mini Glenoid Guide Pin Guide Round
Ascension Orthopedics, Inc.
GPG-0940-042-000
Not in Commercial Distribution

  • M269GG09400420001 ()
  • 10381780245315 ()

  • 7.0 in L x .083 in inner dia
GPG-0940-042-000

  • Orthopaedic guidewire, reusable

Integra® - 10381780244851

Surgical Instruments Implant Extractor
Ascension Orthopedics, Inc.
EXT10001
In Commercial Distribution

  • M269EXT100011 ()
  • 10381780244851 ()

  • 4.75 in L x .25 in W tip
EXT-100-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Titan™ - 10381780244660

Titan™ Reverse Shoulder System The baseplate boss drill is used with the reverse shoulder system.
Ascension Orthopedics, Inc.
DRL096007501
In Commercial Distribution

  • M269DRL0960075011 ()
  • 10381780244660 ()

  • .320 in major dia; .424 in L thread
DRL-0960-075-01

  • Cannulated surgical drill bit, single-use

Integra® - 10381780244653

Integra®Surgical Instruments The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL096006801
In Commercial Distribution

  • M269DRL0960068011 ()
  • 10381780244653 ()

  • 6.0 in L x .110 in dia tip
DRL-0960-068-01

  • Cannulated surgical drill bit, single-use

Integra® - 10381780244646

Integra®Surgical Instruments The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL096006101
In Commercial Distribution

  • M269DRL0960061011 ()
  • 10381780244646 ()

  • 6.0 in L x .098 in dia tip
DRL-0960-061-01

  • Cannulated surgical drill bit, single-use

Titan™ - 10381780244615

Titan™ Total Shoulder System The cannulated peg drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DRL-0923-047-001
In Commercial Distribution

  • M269DRL09230470011 ()
  • 10381780244615 ()

  • .320 in major dia; .640 in L flute
DRL-0923-047-001

  • Cannulated surgical drill bit, single-use

Titan™ - 10381780244608

Titan™ Total Shoulder System The glenoid solid peg drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DRL092208001
In Commercial Distribution

  • M269DRL0922080011 ()
  • 10381780244608 ()

  • .312 in major dia; .705 in L thread
DRL-0922-080-001

  • Cannulated surgical drill bit, single-use

Titan™ - 10381780244592

Titan™ Total Shoulder System The glenoid short solid peg drill is used with the total shoulder system.
Ascension Orthopedics, Inc.
DRL-0920-080-001
In Commercial Distribution

  • M269DRL09200800011 ()
  • 10381780244592 ()

  • .320 in major dia; .705 in L thread
DL0920080001

  • Cannulated surgical drill bit, single-use

Titan™ - 10381780244370

Titan™ Total Shoulder System The canal osteotomy cover is used with the Titan Total Shoulder System.
Ascension Orthopedics, Inc.
CVR0920077S
In Commercial Distribution

  • M269CVR0920077S1 ()
  • 10381780244370 ()

  • 1.20 in L x 1.40 in W; Small
CVR-0920-077S

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780244363

Titan™ Total Shoulder System The canal osteotomy cover is used with the Titan Total Shoulder System.
Ascension Orthopedics, Inc.
CVR0920077L
In Commercial Distribution

  • M269CVR0920077L1 ()
  • 10381780244363 ()

  • 1.50 in L x 1.75 in W; Large
CVR-0920-077L

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780244356

Titan™ Total Shoulder System The trial osteotomy cover is used with the Titan Total Shoulder System.
Ascension Orthopedics, Inc.
CVR0920076S
In Commercial Distribution

  • M269CVR0920076S1 ()
  • 10381780244356 ()

  • 1.40 in L x 1.20 in W; Small
CVR-0920-076S

  • Orthopaedic implant/instrument assembling device

Titan™ - 10381780244349

Titan™ Total Shoulder System The trial osteotomy cover is used with the Titan Total Shoulder System.
Ascension Orthopedics, Inc.
CVR0920076L
In Commercial Distribution

  • M269CVR0920076L1 ()
  • 10381780244349 ()

  • 1.75 in L x 1.50 in W; Large
CVR-0920-076L

  • Orthopaedic implant/instrument assembling device

TITAN™ - 10381780258353

The Fin-Lock Punch is used to impact the bone for proper fit of the glenoid. It can also be used to further pressurize the cement.
Ascension Orthopedics, Inc.
PN-0926-001
In Commercial Distribution

  • M269PN09260011 ()
  • 10381780258353 ()

  • 8.0 in L x 1.5 in end diameter


  • Bone cutter

Integra® External Fixation System - 10381780125136

The extended compression distraction nut is manufactured from stainless steel and is used to secure components in the Integra External Fixation System.
Ascension Orthopedics, Inc.
12224216
In Commercial Distribution

  • 10381780125136 ()

  • .59 in H x .394 in top dia
12224216

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125129

The conical washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel and is convex.
Ascension Orthopedics, Inc.
12224209
In Commercial Distribution

  • 10381780125129 ()

  • .469 in outer dia x .118 in depth
12224209

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125112

The conical washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel and is concave.
Ascension Orthopedics, Inc.
12224208
In Commercial Distribution

  • 10381780125112 ()

  • .472 in outer dia x .118 in depth
12224208

  • External orthopaedic fixation system, reusable

Titan™ - 10381780124795

The glenoid sizer is used to visualize the implant size and anticiapte the amount of bone resection.
Ascension Orthopedics, Inc.
SR0920052003
In Commercial Distribution

  • M269SZR09200520031 ()
  • 10381780124795 ()

  • L; 1.55 in L x 1.14 in W
SZR-0920-052-003

  • Surgical implant template, reusable

Titan™ - 10381780124788

The glenoid sizer is used to visualize the implant size and anticiapte the amount of bone resection.
Ascension Orthopedics, Inc.
SR0920052002
In Commercial Distribution

  • M269SZR09200520021 ()
  • 10381780124788 ()

  • M; 1.45 in L x 1.06 in W
SZR-0920-052-002

  • Surgical implant template, reusable

Titan™ - 10381780124771

The glenoid sizer is used to visualize the implant size and anticiapte the amount of bone resection.
Ascension Orthopedics, Inc.
SR0920052001
In Commercial Distribution

  • M269SZR09200520011 ()
  • 10381780124771 ()

  • S; 1.35 in L x .98 in W
SZR-0920-052-001

  • Surgical implant template, reusable

Titan™ - 10381780124764

The glenoid sizer is used to visualize the implant size and anticiapte the amount of bone resection.
Ascension Orthopedics, Inc.
SR0920052000
In Commercial Distribution

  • M269SZR09200520001 ()
  • 10381780124764 ()

  • XS; 1.25 in L x .90 in W
SZR-0920-052-000

  • Surgical implant template, reusable

Integra® - 10381780000655

INTEGRA® Meshed Dermal Regeneration Template 8in. x 10in. (20cm x 25cm)
Integra Lifesciences Corporation
MDRT8101
In Commercial Distribution

  • M269MDRT81011 ()
  • 10381780000655 ()

  • 8 in x 10 in
  • 20cm x 25cm
MDRT8101

  • Collagen wound matrix dressing

Integra® - 10381780000624

INTEGRA® Meshed Dermal Regeneration Template 2in. x 2in. (5cm x 5cm)
Integra Lifesciences Corporation
MDRT2021
In Commercial Distribution

  • M269MDRT20211 ()
  • 10381780000624 ()

  • 5cm x 5cm
  • 2 in x 2 in
MDRT2021

  • Collagen wound matrix dressing

Integra® External Fixation System - 10381780125310

The round speed nut is used for quick temporary stabilization of the strut to the ring.
Ascension Orthopedics, Inc.
12224214
In Commercial Distribution

  • 10381780125310 ()

  • .87 in major dia x .560 in H
12224214

  • External orthopaedic fixation system, reusable

Titan™ - 10381780124078

The Glenoid Pegged Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TL092003003P
In Commercial Distribution

  • M269TRL092003003P1 ()
  • 10381780124078 ()

  • L; 1.55 in L x 1.14 in W
TRL-0920-030-03P

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780124054

The Glenoid Pegged Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TL092003002P
In Commercial Distribution

  • M269TRL092003002P1 ()
  • 10381780124054 ()

  • M; 1.45 in L x 1.06 in W
TRL-0920-030-02P

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780124030

The Glenoid Pegged Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TL092003001P
In Commercial Distribution

  • M269TRL092003001P1 ()
  • 10381780124030 ()

  • S; 1.35 in L x .98 in W
TRL-0920-030-01P

  • Shoulder glenoid fossa prosthesis trial

Titan™ - 10381780124016

The Glenoid Pegged Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TL092003000P
In Commercial Distribution

  • M269TRL092003000P1 ()
  • 10381780124016 ()

  • XS; 1.25 in L x .90 in W
TRL-0920-030-00P

  • Shoulder glenoid fossa prosthesis trial

Uni-Patch - 10884521208346

510-ST, Stainless Steel, 40 Gel
Cardinal Health, Inc.
EP84609
In Commercial Distribution

  • 10884521208346 ()
  • 20884521208343 ()

  • Length, 2-3/4, IN; Width, 1-3/8, IN;
EP84609

  • Transcutaneous electrical stimulation electrode, single-use

Uni-Patch - 10884521208322

555-ST, Stainless Steel, Blue Gel
Cardinal Health, Inc.
EP85571
In Commercial Distribution

  • 10884521208322 ()
  • 20884521208329 ()

  • Length, 3-3/4, IN; Width, 1-3/4, IN;
EP85571

  • Transcutaneous electrical stimulation electrode, single-use

Curity - 10884521553590

Eye Pad,Oval
Cardinal Health, Inc.
2841
Not in Commercial Distribution

  • 20884527020581 ()
  • 10884521553590 ()
  • 10884527020584 ()

  • Length, 2-5/8, IN; Width, 1-5/8, IN;
2841

  • Eye pad

TWIST DRILL - 00880304409842

No Description
Biomet Orthopedics, LLC
908406
In Commercial Distribution

  • 00880304409842 ()

  • DIA. 5/64 IN.(2.0MM), LENGTH: 5 IN.
908406

  • Fluted surgical drill bit, single-use

TWIST - 00880304360037

No Description
Biomet Orthopedics, LLC
35-463016
In Commercial Distribution

  • 70880304360036 ()
  • 00880304360037 ()

  • DIA. 1/4 IN.(6.4MM), LENGTH: 5 IN.
35-463016

  • Fluted surgical drill bit, reusable

TWIST - 00880304360020

No Description
Biomet Orthopedics, LLC
35-463012
In Commercial Distribution

  • 00880304360020 ()

  • DIA. 3/16 IN.(4.8MM), LENGTH: 5 IN.
35-463012

  • Fluted surgical drill bit, reusable

TWIST - 00880304360006

No Description
Biomet Orthopedics, LLC
35-463010
In Commercial Distribution

  • 70880304360005 ()
  • 00880304360006 ()

  • DIA. 5/32 IN.(4.0MM), LENGTH: 5 IN.
35-463010

  • Fluted surgical drill bit, reusable

TWIST - 00880304359987

No Description
Biomet Orthopedics, LLC
35-463008
In Commercial Distribution

  • 00880304359987 ()

  • DIA. 1/8 IN.(3.2MM), LENGTH: 5 IN.
35-463008

  • Fluted surgical drill bit, reusable

TWIST - 00880304359970

No Description
Biomet Orthopedics, LLC
35-463007
In Commercial Distribution

  • 00880304359970 ()

  • DIA. 7/64 IN.(2.7MM), LENGTH: 5 IN.
35-463007

  • Fluted surgical drill bit, reusable

TWIST - 00880304359963

No Description
Biomet Orthopedics, LLC
35-463006
In Commercial Distribution

  • 00880304359963 ()

  • DIA. 3/32 IN.(2.4MM), LENGTH: 5 IN.
35-463006

  • Fluted surgical drill bit, reusable

TWIST - 00880304359956

No Description
Biomet Orthopedics, LLC
35-463005
In Commercial Distribution

  • 70880304359955 ()
  • 00880304359956 ()

  • DIA. 5/64 IN.(2.0MM), LENGTH: 5 IN.
35-463005

  • Fluted surgical drill bit, reusable

TWIST - 00880304359949

No Description
Biomet Orthopedics, LLC
35-463004
In Commercial Distribution

  • 00880304359949 ()

  • DIA. 1/16 IN.(1.6MM), LENGTH: 5 IN.
35-463004

  • Fluted surgical drill bit, reusable

Integra® - 10381780365020

Cup and Cone Reamer 16 mm Cup Reamer
Ascension Orthopedics, Inc.
CCR8950116
In Commercial Distribution

  • 10381780365020 ()

  • 3.30 in L x .630 ± 0.04 in dia
CCR-895-01-16

  • Bone-resection orthopaedic reamer, reusable

CS1304A HVG Leads - 00860009424869

Electrode Accessories, (4) - 2 in X 2 in Pad + (1) - 4 in X 7 in Pad
Control Solutions LLC
Electrode Accessories, (4) - 2 in X 2 in Pad + (1) - 4 in X 7 in Pad
In Commercial Distribution

  • 00860009424869 ()


  • Physical therapy ultrasound/neuromuscular stimulation system

Visalys CemCore Try In Paste - E217135941

Visalys CemCore Try In Paste Dark (A4) 1 x 1,4 ml + 5 Application tips
Kettenbach GmbH & Co. KG
13594
In Commercial Distribution

  • E217135941 ()
13594

  • Dental composite resin

Visalys CemCore Try In Paste - E217135931

Visalys CemCore Try In Paste Opaque 1 x 1,4 ml + 5 Application tips
Kettenbach GmbH & Co. KG
13593
In Commercial Distribution

  • E217135931 ()
13593

  • Dental composite resin

Visalys CemCore Try In Paste - E217135921

Visalys CemCore Try In Paste Universal (A2/A3) 1 x 1,4 ml + 5 Application tips
Kettenbach GmbH & Co. KG
13592
In Commercial Distribution

  • E217135921 ()
13592

  • Dental composite resin

Visalys CemCore Try In Paste - E21713592

Visalys CemCore Try In Paste Universal (A2/A3) 1 x 1,4 ml + 5 Application tips
Kettenbach GmbH & Co. KG
13592
Not in Commercial Distribution

  • E21713592 ()
13592

  • Dental composite resin

Visalys CemCore Try In Paste - E217135911

Visalys CemCore Try In Paste Bleach 1 x 1,4 ml + 5 Application tips
Kettenbach GmbH & Co. KG
13591
In Commercial Distribution

  • E217135911 ()
13591

  • Dental composite resin

Visalys CemCore Try In Paste - E217135901

Visalys CemCore Try In Paste Translucent 1 x 1,4 ml + 5 Application tips
Kettenbach GmbH & Co. KG
13590
In Commercial Distribution

  • E217135901 ()
13590

  • Dental composite resin
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