ACTIS 201007100

GUDID 10603295393986

ACTIS RETAINING STEM INSERTER

DEPUY (IRELAND)

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10603295393986
• NIH Device Record Key: 25a66a30-8b42-4786-981b-e7f2fe619a03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIS
• Version Model Number: 2010-07-100
• Catalog Number: 201007100
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295393986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150862

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

[10603295393986]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-11-13

On-Brand Devices [ACTIS]

• 10603295394006: ACTIS CURVED INSERTER SHAFT
• 10603295393993: ACTIS STRAIGHT INSERTER SHAFT
• 10603295393986: ACTIS RETAINING STEM INSERTER
• 10603295393924: ACTIS FLX REAMER CASE BASE
• 10603295393917: ACTIS CORE CASE BASE
• 10603295393887: ACTIS BROACH CASE BASE
• 10603295526841: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526834: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526827: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526810: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526803: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526797: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526780: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526773: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526766: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526759: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526742: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526735: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526728: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLL
• 10603295526711: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526704: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526698: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526681: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526674: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526667: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526650: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526643: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526636: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526629: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526612: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526605: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295526599: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STANDARD
• 10603295531920: ACTIS HIP SYSTEM IMPLANT XRAY TEMPLATES
• 10603295548683: ACTIS HIP SYSTEM BROACH SIZE 9
• 10603295548676: ACTIS HIP SYSTEM BROACH SIZE 8
• 10603295548669: ACTIS HIP SYSTEM BROACH SIZE 7
• 10603295548652: ACTIS HIP SYSTEM BROACH SIZE 6
• 10603295548645: ACTIS HIP SYSTEM BROACH SIZE 5
• 10603295548638: ACTIS HIP SYSTEM BROACH SIZE 4
• 10603295548621: ACTIS HIP SYSTEM BROACH SIZE 3
• 10603295548614: ACTIS HIP SYSTEM BROACH SIZE 2
• 10603295548607: ACTIS HIP SYSTEM BROACH SIZE 12
• 10603295548591: ACTIS HIP SYSTEM BROACH SIZE 11
• 10603295548584: ACTIS HIP SYSTEM BROACH SIZE 10
• 10603295548577: ACTIS HIP SYSTEM BROACH SIZE 1
• 10603295548560: ACTIS HIP SYSTEM BROACH SIZE 0
• 10603295455523: ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 12 HIGH COLLAR) CE
• 10603295455516: ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 12 STD COLLAR) CE
• 10603295421054: ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLLAR SIZE 12 Non-CE
• 10603295421047: ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STD COLLAR SIZE 12 Non-CE