GUIDE PIN/SCREW GP004.89.31 STE

GUDID 24053613208950

Gebr. Brasseler GmbH & Co. KG

Intraoperative bone pin/screw, sterile

• Primary Device ID: 24053613208950
• NIH Device Record Key: aeb4e03d-a756-4c58-a7b9-3274995f463d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUIDE PIN/SCREW
• Version Model Number: GP004.89.31.YT
• Catalog Number: GP004.89.31 STE
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14053613208953 [Primary]
GS1	24053613208950 [Package]; Contains: 14053613208953; Package: [1 Units]; In Commercial Distribution
GS1	84053613208952 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, 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: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [GUIDE PIN/SCREW]

• 24053613279042: 02-029-99-1001
• 24053613279035: 02-029-99-1002
• 24053613279028: 02-029-99-1005
• 24053613279011: 02-029-99-1003
• 24053613278991: OC905.030.032 STE
• 24053613278984: OC907.067.032 STE
• 24053613278977: OC907A.076.032 STE
• 24053613278960: OC005.076.032 STE
• 24053613278953: OC007.075.032 STE
• 24053613278946: OC001A.089.032 STE
• 24053613278892: OC909.027.032 STE
• 24053613278885: OC908.056.032 STE
• 24053613278878: OC907.067.032 STE
• 24053613278830: OC901.033.032 STE
• 14053613278819: OC901.050.032 STE
• E226050900MB1: SP-10001-00-00
• E226050899MB1: SP-10000-00-00
• 24053613265403: SP-80010-10-00
• 24053613216375: 800-02-502
• E226049312YT1: 800-02-505
• 24053613279158: OC910.170.040 STE
• 24053613279141: OC910.140.040 STE
• 14053613279137: OC910.140.032 STE
• 14053613279120: OC910.110.040 STE
• 14053613279113: OC910.110.032 STE
• 14053613279106: OC910.080.040 STE
• 24053613279660: 800-02-503
• 24061144348984: GP001A.76.31.MH
• 24053613281380: GP003B.76.32.MG
• 24053613279257: GS906.93.55.MF
• 84053613279242: GS906.80.32.MF
• 24053613279233: GS906.110.32.MF
• 24053613279004: GP002A.89.32.MG
• 24053613278861: GS907A.76.32.MG
• 24053613278854: GP005.76.32.MG
• 24053613278847: GP007.75.32.MG
• 24053613278823: GS902.150.32.MG
• 24053613278809: GP001.89.32.MG
• 24053613265588: GP006.76.32.MF
• 24053613265526: GP003A.38.30.MF
• 24053613265465: GP005A.76.32.MF
• 24053613265434: GP003A.35.30.MF
• 24053613265373: GP003A.19.30.MF
• 24053613265342: GS906.73.55.MF
• 84053613265115: GS906A.110.32.TH
• 14053613215531: GP003A.27.30.MB
• 84053613215516: GS906.93.55.MB
• 84053613215509: GS906.80.32.MB
• 84053613215493: GS906.110.32.MB
• 24053613208950: GP004.89.31.YT