Guide Pin 2021-1209

GUDID 84053613292449

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 84053613292449
• NIH Device Record Key: 6c269b3a-81b8-498a-9b53-636f84ffd85b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pin
• Version Model Number: 2021-1209
• Catalog Number: 2021-1209
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 20
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053613292443 [Direct Marking]
GS1	14053613292440 [Primary]
GS1	84053613292449 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

[84053613292449]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

On-Brand Devices [Guide Pin]

• 24053613285968: Guide Pin Ø 3,20mm
• 24053613285944: Guide Pin Ø 3,20mm
• 24053613285937: Guide Pin Ø 3,20mm
• 24053613291990: HTZ-2P-020-00
• 24053613291891: HTZ-4P-020-00
• 24053613291846: HTS-4P-03-090
• 24053613292041: HTSN-2P-76032
• 24053613291907: HTD-4P-02-300
• 24053613291839: HTS-4P-2038A
• 24053613292126: HTD-4P-00-777
• 24053613291853: HTS-4P-4-003A
• 84053613292456: 2024-0616
• 84053613292449: 2021-1209