Alians Fragment Specific KIT-XW2D

GUDID 03700569640927

NEWCLIP TECHNICS

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 03700569640927
• NIH Device Record Key: d67ec8b6-f435-445c-883c-9eb700c0e367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alians Fragment Specific
• Version Model Number: KIT-XW2D
• Catalog Number: KIT-XW2D
• Company DUNS: 263281904
• Company Name: NEWCLIP TECHNICS
• 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	03700569640927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170843

FDA Product Code

• HRS: Plate, 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: 2024-11-25
• Device Publish Date: 2024-11-15

On-Brand Devices [Alians Fragment Specific]

• 03700569652722: KIT-XEN1G
• 03700569652715: KIT-XEN1D
• 03700569652708: KIT-XES1G
• 03700569652692: KIT-XES1D
• 03700569652524: KIT-XW3G
• 03700569652517: KIT-XW3D
• 03700569642013: DTDRNS3-ST
• 03700569642006: DTDRNS3
• 03700569641672: KIT-XS3D
• 03700569641665: KIT-XN3G
• 03700569641658: KIT-XN3D
• 03700569640934: KIT-XW2G
• 03700569640927: KIT-XW2D
• 03700569640910: KIT-XS4G
• 03700569640903: KIT-XS4D
• 03700569640897: KIT-XS2G
• 03700569640880: KIT-XS2D
• 03700569640873: KIT-XS1G
• 03700569640866: KIT-XS1D
• 03700569640859: KIT-XNS1G
• 03700569640835: KIT-XN2G
• 03700569640804: KIT-XN1D
• 03700569637484: DTDRNS2-ST
• 03700569637477: DTDRNS2
• 03700569637460: DTDRNS1-ST
• 03700569637453: DTDRNS1
• 03700569602987: ETSIS4-ST
• 03700569602970: ETSIS4
• 03700569602963: ETSIS3-ST
• 03700569602956: ETSIS3
• 03700569602949: ETSIS2-ST
• 03700569602932: ETSIS2
• 03700569602925: ETSIS1-ST
• 03700569602918: ETSIS1