254508

GUDID 10886705013005

ABSOLUTE Absorbable Interference Screw 10 x 30mm

DEPUY MITEK, LLC

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 10886705013005
• NIH Device Record Key: 38efefaf-9d87-4984-bd83-e1162e16568a
• Commercial Distribution Discontinuation: 2021-01-28
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 254508
• Catalog Number: 254508
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705013005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990454

FDA Product Code

• HWC: Screw, fixation, bone

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: 2021-01-07
• Device Publish Date: 2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

• 20886705011022 - STRAIGHTSHOT: 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm
• 20886705011039 - STRAIGHTSHOT: 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm
• 20886705011060 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 7.5mm
• 20886705011077 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm
• 20886705011084 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm
• 20886705011091 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm
• 20886705011107 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm
• 10886705012480 - COR: 2024-08-20 Mitek COR Plunger 4mm, 5-25mm (Plus or Minus 10 Percent)