Momentum

GUDID 00814386023078

Screw, polyaxial, Ø 4.5mm, length 25mm, cannulated

Ulrich Medical Usa, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00814386023078
• NIH Device Record Key: 05cc6a0c-3f9e-4ab2-9f11-da7280c22813
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Momentum
• Version Model Number: UU051-01-4525
• Company DUNS: 624083866
• Company Name: Ulrich Medical Usa, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 636-519-0268
• Email: info@ulrichmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814386023078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191932

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00814386023078]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-11-01

On-Brand Devices [Momentum ]

• 00814386025775: Ball tip probe, curved
• 00814386025768: Starter awl, 10mm depth, 1/4"-square
• 00814386025751: Iliac tap, Ø 10.0mm, cannulated
• 00814386025744: Iliac tap, Ø 9.0mm, cannulated
• 00814386025737: Iliac tap, Ø 8.0mm, cannulated
• 00814386025720: Iliac tap, Ø 7.0mm, cannulated
• 00814386025713: Tap, Ø 8.5mm, cannulated, 1/4"-square
• 00814386025706: Tap, Ø 7.5mm, cannulated, 1/4"-square
• 00814386025690: Tap, Ø 6.5mm, cannulated, 1/4"-square
• 00814386025683: Tap, Ø 5.5mm, cannulated, 1/4"-square
• 00814386025676: Tap, Ø 4.5mm, cannulated, 1/4"-square
• 00814386025669: Tap, Ø 8.5mm, non-cannulated, 1/4"-square
• 00814386025652: Tap, Ø 7.5mm, non-cannulated, 1/4"-square
• 00814386025645: Tap, Ø 6.5mm, non-cannulated, 1/4"-square
• 00814386025638: Tap, Ø 5.5mm, non-cannulated, 1/4"-square
• 00814386025621: Tap, Ø 4.5mm, non-cannulated, 1/4"-square
• 00814386025614: Tap, Ø 4.0mm, non-cannulated, 1/4"-square
• 00814386025607: Sterilization case, revision and connector module, outer case
• 00814386025591: Sterilization case, iliac module, outer case
• 00814386025584: Sterilization case, reduction screw module, outer case
• 00814386025577: Sterilization case, implants, outer case
• 00814386025560: Sterilization case, instrument module #2, outer case
• 00814386025553: Sterilization case, instrument module #1, outer case
• 00814386025546: Coronal bender, right, Ø 6.0mm
• 00814386025539: Coronal bender, left, Ø 6.0mm
• 00814386025522: in situ rod bender, right, Ø 6.0mm
• 00814386025515: in situ rod bender, left, Ø 6.0mm
• 00814386025508: Rod rotator, 5mm hex
• 00814386025492: Screwdriver for locking screw, long, SR25, self-retaining
• 00814386025485: Screwdriver for reduction screws, SR20, 1/4"-square
• 00814386025478: Axial connector, Ø 5.5/Ø 6.0mm to Ø 4.0mm, long
• 00814386025461: Parallel connector, Ø 4.0mm to Ø 5.5/Ø 6.0mm, closed to open
• 00814386025454: Parallel connector, Ø 4.0mm to Ø 5.5/Ø 6.0mm, closed to open
• 00814386025447: Axial connector, for rod Ø 5.5mm /Ø 6.0mm, long
• 00814386025409: Domino connector, Ø 5.5/Ø 6.0mm to Ø 4.0mm
• 00814386025393: Domino connector, for rod Ø 5.5/Ø 6.0mm
• 00814386025386: Axial rod reducer, socket wrench, 1/4"-square
• 00814386025379: Crosslink measurement guide
• 00814386025362: Crosslink screwdriver, self-retaining
• 00814386025355: Iliac awl, Ø 6.9mm, cannulated
• 00814386025348: Iliac awl, Ø 6.2mm, cannulated
• 00814386025331: Iliac awl, Ø 5.4mm, cannulated
• 00814386025324: Rod template, 300mm
• 00814386025317: Rod template, 150mm
• 00814386025300: Screwdriver for iliac screws, SR25, 1/4"-square
• 00814386025294: Iliac tap, Ø 10.0mm, cannulated
• 00814386025287: Iliac tap, Ø 9.0mm, cannulated
• 00814386025270: Iliac tap, Ø 8.0mm, cannulated
• 00814386025263: Iliac tap, Ø 7.0mm, cannulated
• 00814386025256: Iliac drill, Ø 4.5mm