OSStaple

GUDID 00810633020548

OSStaple 07X05W1.2

Biomedical Enterprises, Inc.

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00810633020548
• NIH Device Record Key: 8245ae55-7761-4bc3-9635-06a5d8a6bf0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSStaple
• Version Model Number: OS-0705W1.2
• Company DUNS: 792619009
• Company Name: Biomedical Enterprises, Inc.
• 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: true
• 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: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com
• Phone: 210-881-0043
• Email: gupton@bme-tx.com

Device Dimensions

• Width: 7 Millimeter
• Width: 7 Millimeter
• Width: 7 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter
• Length: 5 Millimeter
• Width: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633020548 [Primary]

FDA Product Code

• JDR: Staple, 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: 3
• Public Version Date: 2020-05-07
• Device Publish Date: 2015-10-24

On-Brand Devices [OSStaple]

• 00810633021330: OSStaple 30 x 30 W2 x 3
• 00810633021323: OSStaple 25 x 22 W2 x 3
• 00810633021262: OSStaple 20 x 15 x 15 W1.5
• 00810633021255: OSStaple 18 x 25 W2
• 00810633021248: OSStaple 18 x 15 x 15 mm implant 2mm diameter legs
• 00810633021149: OSStaple 15 x 18 W2
• 00810633021132: OSStaple 15 x 18 W1.5
• 00810633021125: OSStaple 15 x 15 W1.5
• 00810633021118: OSStaple 15 x 12 W1.5
• 00810633021101: OSStaple 13 x 10 x 10 W1.5
• 00810633021095: OSStaple 11 x 19 x 17 W1.5
• 00810633021088: OSStaple 11 x 17 x 15 W1.5
• 00810633021071: OSStaple 11 x 15 x 13 W1.5
• 00810633021064: OSStaple 11 x 08 W1.5
• 00810633021057: OSSplate 15 x 10
• 00810633021040: OSSplate 15 x 08
• 00810633021033: OSSplate 15 x 06
• 00810633020661: OSStaple 18X30W2X3
• 00810633020654: OSStaple 20X20W2
• 00810633020647: OSStaple 18X18X15W2
• 00810633020623: OSStaple 18X25W2
• 00810633020609: OSStaple 09X07W1.2
• 00810633020593: OSStaple 15X15W2
• 00810633020586: OSStaple 20X20 W2X3
• 00810633020579: OSStaple 15X12W2
• 00810633020562: OSStaple 11X10W1.5
• 00810633020555: OSStaple 09X07W1.5
• 00810633020548: OSStaple 07X05W1.2
• 00810633020395: Step OSStaple 20X20X20 W2X3
• 00810633020388: OSStaple 07X05W1.5