Reign Medical

GUDID 00854325007127

Clench Staple, 11mm x 10mm

F & A Foundation LLC

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00854325007127
• NIH Device Record Key: 2fa9f4a5-4a13-41c6-b5ea-282a9d9f1910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reign Medical
• Version Model Number: 152-41110
• Company DUNS: 080543801
• Company Name: F & A Foundation 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854325007127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173775

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [Reign Medical]

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• 00854325007172: Clench Staple, 18mm x 18mm
• 00854325007165: Clench Staple, 18mm x 15mm
• 00854325007158: Clench Staple, 15mm x 15mm
• 00854325007141: Clench Staple, 15mm x 12mm
• 00854325007134: Clench Staple, 13mm x 10mm
• 00854325007127: Clench Staple, 11mm x 10mm
• 00854325007110: Clench Staple, 9mm x 7mm
• 00854325007103: Clench Staple, 7mm x 5mm
• 00854325007097: Clench Staple Sizer
• 00854325007080: Clench Staple System, 20mm x 20mm
• 00854325007073: Clench Staple System, 18mm x 18mm
• 00854325007066: Clench Staple System, 18mm x 15mm
• 00854325007059: Clench Staple System, 15mm x 15mm
• 00854325007042: Clench Staple System, 15mm x 12mm
• 00854325007035: Clench Staple System, 13mm x 10mm
• 00854325007028: Clench Staple System, 11mm x 10mm
• 00854325007011: Clench Staple System, 9mm x 7mm
• 00854325007004: Clench Staple System, 7mm x 5mm