RECLAIM 197723240

GUDID 10603295077367

RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 23mm X 240mm ANGLED

DEPUY (IRELAND)

Uncoated hip femur prosthesis, modular

• Primary Device ID: 10603295077367
• NIH Device Record Key: b4e4f006-2f2b-4b51-b2e8-0456050ce30c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RECLAIM
• Version Model Number: 1977-23-240
• Catalog Number: 197723240
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295077367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102080

FDA Product Code

• KWA: Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-05-11
• Device Publish Date: 2015-03-24

On-Brand Devices [RECLAIM]

• 10603295156383: RECLAIM PROXIMAL TRIAL SHAFT INSERTER
• 10603295156161: RECLAIM DISTAL STEM INSERTER
• 10603295155904: RECLAIM PRONGED STEM STABILIZER
• 10603295157113: RECLAIM TAPERED REAMER CASE 18-27x290
• 10603295157090: RECLAIM TAPERED REAMER CASE 28-31
• 10603295157076: RECLAIM TAPERED REAMER CASE 22-27
• 10603295157069: RECLAIM TAPERED REAMER TRAY 14-21
• 10603295157052: RECLAIM TAPERED REAMER INDEX 14-21
• 10603295157038: RECLAIM TAPERED REAMER CASE 14-21
• 10603295156437: RECLAIM DISASSEMBLY CASE
• 10603295156413: RECLAIM ASSEMBLY CASE
• 10603295156390: RECLAIM CONICAL CORE CASE
• 10603295156406: RECLAIM CONICAL CORE KIT
• 10603295077534: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 31mm X 290mm ANGLED
• 10603295077527: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 31mm X 240mm ANGLED
• 10603295077510: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 31mm X 190mm ANGLED
• 10603295077503: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 29mm X 290mm ANGLED
• 10603295077497: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 29mm X 240mm ANGLED
• 10603295077480: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 29mm X 190mm ANGLED
• 10603295077473: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 27mm X 290mm ANGLED
• 10603295077466: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 27mm X 240mm ANGLED
• 10603295077459: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 27mm X 190mm ANGLED
• 10603295077442: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 26mm X 240mm ANGLED
• 10603295077435: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 26mm X 190mm ANGLED
• 10603295077428: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 25mm X 290mm ANGLED
• 10603295077411: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 25mm X 240mm ANGLED
• 10603295077404: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 25mm X 190mm ANGLED
• 10603295077398: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 24mm X 240mm ANGLED
• 10603295077381: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 24mm X 190mm ANGLED
• 10603295077374: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 23mm X 290mm ANGLED
• 10603295077367: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 23mm X 240mm ANGLED
• 10603295077350: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 23mm X 190mm ANGLED
• 10603295077343: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 22mm X 240mm ANGLED
• 10603295077336: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 22mm X 190mm ANGLED
• 10603295077329: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 21mm X 290mm ANGLED
• 10603295077312: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 21mm X 240mm ANGLED
• 10603295077305: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 21mm X 190mm ANGLED
• 10603295077299: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 20mm X 290mm ANGLED
• 10603295077282: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 20mm X 240mm ANGLED
• 10603295077275: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 20mm X 190mm ANGLED
• 10603295077268: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 19mm X 290mm ANGLED
• 10603295077251: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 19mm X 240mm ANGLED
• 10603295077244: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 19mm X 190mm ANGLED
• 10603295077237: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 18mm X 290mm ANGLED
• 10603295077220: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 18mm X 240mm ANGLED
• 10603295077213: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 18mm X 190mm ANGLED
• 10603295077206: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 17mm X 240mm ANGLED
• 10603295077190: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 17mm X 190mm ANGLED
• 10603295077183: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 16mm X 240mm ANGLED
• 10603295077176: RECLAIM REVISION HIP SYSTEM DISTAL TAPERED STEM 16mm X 190mm ANGLED