Ascension® IMP-100-00D

GUDID M269IMP10000D1

Ascension® MCP Distal impactor

Ascension Orthopedics, Inc.

Orthopaedic implant impactor

• Primary Device ID: M269IMP10000D1
• NIH Device Record Key: a7da781f-8683-4c06-98c9-97ee9dab6386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension®
• Version Model Number: IMP10000D
• Catalog Number: IMP-100-00D
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780245681 [Primary]
HIBCC	M269IMP10000D1 [Secondary]

FDA Product Code

• HWA: IMPACTOR

Sterilization

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

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

[M269IMP10000D1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-08-07
• Device Publish Date: 2017-09-05

On-Brand Devices [Ascension®]

• M269CSA100061: Integra®Surgical Instruments The MCP Caddy is a smaller, removable container that rests within
• M269CSA100051: Integra®Surgical Instruments The Base is the bottom portion wherein devices are placed.
• M269OSG10000P1: Ascension® MCP Osteotomy Guide, Proximal
• M269OSG10000D1: Ascension® MCP Osteotomy Guide, Distal
• M269IMP10000P1: Ascension® MCP Proximal impactor
• M269IMP10000D1: Ascension® MCP Distal impactor
• M269BRH10105P1: MCP Proximal Cutting Broach Sz. 05
• M269BRH10105D1: MCP Distal Cutting Broach Sz. 05
• M269BRH10040P1: MCP, Broach, Proximal, Sz. 40
• M269BRH10040D1: MCP, Broach, Distal, Sz. 40
• M269BRH10030P1: MCP, Broach, Proximal, Sz. 30
• M269BRH10030D1: MCP, Broach, Distal, Sz. 30
• M269BRH10020P1: MCP, Broach, Proximal, Sz. 20
• M269BRH10020D1: MCP, Broach, Distal, Sz. 20
• M269BRH10010P1: MCP, Broach, Proximal, Sz. 10
• M269BRH10010D1: MCP, Broach, Distal, Sz. 10
• M269TRL500401: Ascension® Silicone MCP, SMCP Trial Size 40
• M269TRL500301: Ascension® Silicone MCP, SMCP Trial Size 30
• M269TRL500201: Ascension® Silicone MCP, SMCP Trial Size 20
• M269TRL500101: Ascension® Silicone MCP, SMCP Trial Size 10
• M269TRL10140P1: Ascension® MCP Proximal Metal Trial Size 40
• M269TRL10140D1: Ascension® MCP Distal Metal Trial Size 40
• M269TRL10130P1: Ascension® MCP Proximal Metal Trial Size 30
• M269TRL10130D1: Ascension® MCP Distal Metal Trial Size 30
• M269TRL10120P1: Ascension® MCP Proximal Metal Trial Size 20
• M269TRL10120D1: Ascension® MCP Distal Metal Trial Size 20
• M269TRL10110P1: Ascension® MCP Proximal Metal Trial Size 10
• M269TRL10110D1: Ascension® MCP Distal Metal Trial Size 10
• M269TRL10105P1: Ascension® MCP Proximal Metal Trial Size 05
• M269TRL10105D1: Ascension® MCP Distal Metal Trial Size 05
• M269TRL500051: Ascension® Silicone MCP, SMCP Trial Size 05
• M269CSA500021: Ascension® PIP Silicone MCP The Silicone MCP Base is the bottom portion wherein devices are pla
• M269CSA500011: Ascension® PIP Silicone MCP The Silicone MCP Lid is the top part of the case which locks onto
• M269TRL500501: The Silicone MCP Trial is used to evaluate component collar contact on osteotomy and stem fit in
• M269TRL10150P1: The Proximal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit
• M269TRL10150D1: The Distal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit in
• M268SILMCPINSTP1: The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint wh
• M268PYROMCPINSTP1: The Ascension MCP is indicated for use as a total joint replacement of index, long, ring, and sm