OrthoMed

GUDID B504OMOM4800570

Provision

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• Primary Device ID: B504OMOM4800570
• NIH Device Record Key: e799ec93-bd1d-4afd-bb2b-2ac9cb14575c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMed
• Version Model Number: OM48-0057
• Company DUNS: 016889401
• Company Name: Provision
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B504OMOM4800570 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-30
• Device Publish Date: 2024-05-22

On-Brand Devices [OrthoMed]

• B504OMOM4801410: OM48-0141
• B504OMOM4801430: OM48-0143
• B504OMOM4801320: OM48-0132
• B504OMOM7107490: OM71-0749
• B504OMOM4801420: OM48-0142
• B504OMOM4800540: OM48-0054
• B504OMOM4801300: OM48-0130
• B504OMOM4800710: OM48-0071
• B504GSOM3900660: OM 39-0066
• B504OMOM4801360: OM48-0136
• B504OMOM04801340: OM048-0134
• B504OMOM4800570: OM48-0057