STERIFLEX HT RAHT-2X13S10

GUDID M695RAHT2X13S100

STERIFLEX HT Ø2.0mm x 13mm - 10

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M695RAHT2X13S100
• NIH Device Record Key: 65116879-a0da-4d3a-9ff0-2d0a3803f2bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIFLEX HT
• Version Model Number: RAHT-2X13S10
• Catalog Number: RAHT-2X13S10
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695RAHT2X13S100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170571

FDA Product Code

• HWC: Screw, 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: 2
• Public Version Date: 2022-01-17
• Device Publish Date: 2019-08-23

On-Brand Devices [STERIFLEX HT]

• M695RAHT2X15S100: STERIFLEX HT Ø2.0mm x 15mm - 10
• M695RAHT2X15C0: STERIFLEX HT Ø2.0mm x 15mm
• M695RAHT2X13S100: STERIFLEX HT Ø2.0mm x 13mm - 10
• M695RAHT2X13C0: STERIFLEX HT Ø2.0mm x 13mm
• M695RAHT25X15S100: STERIFLEX HT Ø2.5mm x 15mm - 10
• M695RAHT25X15C0: STERIFLEX HT Ø2.5mm x 15mm
• M695RAHT3X15C0: STERIFLEX HT Ø3.0mm x 15mm
• M695RAHT010110: Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6") Kit
• M695RAHT010090: Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6") Kit
• M695RAHT010000: Mini Fixed AO Handle