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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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Origin Short Neck Hip Stem - 09348215023867

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1105
In Commercial Distribution

  • 09348215023867 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023850

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1005
In Commercial Distribution

  • 09348215023850 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023843

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0905
In Commercial Distribution

  • 09348215023843 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051914

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1804
In Commercial Distribution

  • 09348215051914 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051907

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1604
In Commercial Distribution

  • 09348215051907 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051891

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1504
In Commercial Distribution

  • 09348215051891 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051884

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1404
In Commercial Distribution

  • 09348215051884 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051877

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1304
In Commercial Distribution

  • 09348215051877 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051860

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1204
In Commercial Distribution

  • 09348215051860 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051853

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1104
In Commercial Distribution

  • 09348215051853 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051846

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1004
In Commercial Distribution

  • 09348215051846 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051839

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0904
In Commercial Distribution

  • 09348215051839 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036454

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1803
In Commercial Distribution

  • 09348215036454 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032562

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1802
In Commercial Distribution

  • 09348215032562 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032555

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1602
In Commercial Distribution

  • 09348215032555 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032548

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1502
In Commercial Distribution

  • 09348215032548 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032524

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1302
In Commercial Distribution

  • 09348215032524 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032517

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1202
In Commercial Distribution

  • 09348215032517 ()


  • Coated femoral stem prosthesis, modular

OrthoMedFlex - M7161111818000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111816000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111815000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1500
In Commercial Distribution

  • M7161111815000 ()
111-18-1500

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111814000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1400
In Commercial Distribution

  • M7161111814000 ()
111-18-1400

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111813000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111812000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111811000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111810000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1000
In Commercial Distribution

  • M7161111810000 ()
111-18-1000

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111809000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0900
In Commercial Distribution

  • M7161111809000 ()
111-18-0900

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111808000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 8, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0800
In Commercial Distribution

  • M7161111808000 ()
111-18-0800

  • Press-fit femoral stem prosthesis

HOC COLLECTION VIAL 30ML - 03700111400863

Device for oocyte collection
LABORATOIRE CCD
HOC COLLECTION VIAL 30ML
In Commercial Distribution

  • 03700111425866 ()
  • 03700111400863 ()

  • Total Volume: 30 Milliliter
1302001

  • Assisted reproduction cryotube

CryoTip® - 00893727002118

CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube

inFlow Intraurethral Valve-Pump - 08625630003003

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003002

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003034

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003027

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump

CODMAN - 10886704072881

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Cerenovus, Inc.
AP-04009
Not in Commercial Distribution

  • 20886704072888 ()
  • 10886704072881 ()
AP04009

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704044109

Models 400 and 550 Implantable Infusion Pump Refill Kit
Cerenovus, Inc.
IP-40820
Not in Commercial Distribution

  • 10886704044109 ()
IP40820

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704044093

MODEL 400 REFILL TUBING SET
Cerenovus, Inc.
IP40812
Not in Commercial Distribution

  • 10886704044093 ()
IP40812

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043829

3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
Cerenovus, Inc.
AP-09150
Not in Commercial Distribution

  • 20886704043826 ()
  • 10886704043829 ()
AP09150

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043775

FOR USE WITH CODMAN 3000 series Refill Kit - CODMAN 3000 Series Implantable Drug Delivery System
Medos International Sàrl
AP-07014
Not in Commercial Distribution

  • 10886704043775 ()
AP07014

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043768

FOR USE WITH: CODMAN 3000 Series Implantable Pump Operating Room Prep Kit Contents: (1) 2.54cm (1 inch) Huber Needle (REF AP-04009) (1) Special Bolus Needle (REF AP-04013-5) (1) Empty Syringe Barrel with Lid assembled to a 33cm (13 inch) Microbore Tubing Set with Clamp Approximate priming volume 0.3mL (3) Instructions for Use Posters
Medos International Sàrl
AP-07004
Not in Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable
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