N/A CS 3993-900

GUDID 04052536176823

Tray including layer for additional components

Ulrich GmbH & Co. KG

Sterilization container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 04052536176823
• NIH Device Record Key: 28430c1b-0545-442c-a40a-2244cbec0d9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: CS 3993-900
• Catalog Number: CS 3993-900
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• 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: false
• 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: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536176823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150650

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

[04052536176823]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-29
• Device Publish Date: 2019-05-21

On-Brand Devices [N/A]

• 04052536184514: Pump tubing - flex for ulrichINJECT CT injectors
• 04052536184088: ulrich Transfer Set, 20 in for USA only: For use with Omnipaque Imaging Bulk Package
• 04052536181216: Spike for CT (CM/NaCl) for ulrichINJECT CT injectors
• 04052536180424: Patient tubing 320 cm for Pump tubing - flex
• 04052536180400: Patient tubing 250 cm for Pump tubing - flex
• 04052536179923: Patient tubing 150 cm for Pump tubing - flex
• 04052536170043: OC screwdriver, flexible, self-retaining, coupling AO
• 04052536170029: Rod reduction instrument
• 04052536169184: Screwdriver, cannulated, with SR 15, coupling AO
• 04052536168972: Outer sleeve for rod pusher (persuader)
• 04052536167326: Layer for mambo screws
• 04052536164622: Box for small OC-implants
• 04052536164615: Box for crosslink, screw-screw
• 04052536164554: Carrier for occipital screws
• 04052536164547: Layer 1 for neon³ OC-module
• 04052536164530: Layer 2 for neon³ OC-module
• 04052536164417: Tray for neon³ OC-module
• 04052536163243: Compression forceps, percutaneous
• 04052536163236: Distraction forceps, percutaneous
• 04052536163137: Inner sleeve for rod pusher (persuader)
• 04052536162055: OC plate bender with handle
• 04052536162031: Counterpart for torque wrench
• 04052536162024: Screwdriver with SR 20, self-retaining
• 04052536161980: Rod pusher (Rocker)
• 04052536161935: Rotating end for CS 3932-04
• 04052536161928: Screwdriver, cannulated, with SR 15
• 04052536136049: Layer for tezo addition set
• 04052536136025: Layer 2 for tezo-A instruments
• 04052536136001: Layer 2 for tezo-P/T instruments
• 04052536135707: Tray for mambo implants & instruments
• 04052536135691: Layer for mambo instruments
• 04052536135684: Layer for mambo instruments
• 04052536135677: Layer for mambo implants
• 04052536123261: Rod inserter with spring, percutaneous for screws, pre-fixation
• 04052536122332: Measuring lever
• 04052536122325: Handle for measuring instrument
• 04052536122271: Inserter for pin
• 04052536122264: Fixation pin
• 04052536122257: Plate holder
• 04052536122240: Shaft for screwdriver, torx 15, with 1/4-inch-coupling
• 04052536122233: Shaft for screwdriver, torx 8, with AO-coupling
• 04052536085866: Hook inserting forceps
• 04052536085811: OC plate bending clamp
• 04052536085798: OC-tap, flexible, for CS 3914-50-XX, coupling AO
• 04052536085781: OC-tap, rigid, for CS 3914-50-XX, coupling AO
• 04052536085705: Screwdriver with SR 20, coupling AO
• 04052536085620: Star grip handle for rod pusher (persuader)
• 04052536085545: Screwhead adjuster
• 04052536085521: Sleeve for screwdriver
• 04052536085484: Insert for Brainlab ICM4