AccuAim( Navigation Guide) 310.100

GUDID 00889024406445

ZIMMER KNEE CREATIONS, INC.

Surgical drill guide, single-use

• Primary Device ID: 00889024406445
• NIH Device Record Key: 07c8699f-0fe4-4741-ba7b-61b3349f3714
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuAim( Navigation Guide)
• Version Model Number: 310.100
• Catalog Number: 310.100
• Company DUNS: 078836317
• Company Name: ZIMMER KNEE CREATIONS, 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: 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: 484-887-8902
• Email: KC.Customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024406445 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-05-19

Devices Manufactured by ZIMMER KNEE CREATIONS, INC.

• 00889024594043 - SCP® PF Knee Kit, 4PK: 2020-07-31
• 00889024594050 - SCP® PF Knee Kit, 4PK: 2020-07-31
• 00889024594067 - SCP® PF Knee Kit, 4PK: 2020-07-31
• 00889024594074 - SCP® PF Knee Kit, 4PK: 2020-07-31
• 00889024594081 - SCP® PF Foot & Ankle Kit, 4PK: 2020-07-31
• 00889024594098 - SCP® PF Foot & Ankle Kit, 4PK: 2020-07-31
• 00889024594104 - SCP® PF Foot & Ankle Kit, 4PK: 2020-07-31
• 00889024594111 - SCP® PF Hip Kit, 4 Pack: 2020-07-31