uNion Cervical Plate System UM102-03-63

GUDID 00814386020275

Standard Cervical Plate, 3-Level, 63mm

Ulrich Medical Usa, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00814386020275
NIH Device Record Key601805b4-0f36-4218-b98e-b95b47788c88
Commercial Distribution StatusIn Commercial Distribution
Brand NameuNion Cervical Plate System
Version Model NumberUM102-03-63
Catalog NumberUM102-03-63
Company DUNS624083866
Company NameUlrich Medical Usa, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814386020275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

[00814386020275]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-29

On-Brand Devices [uNion Cervical Plate System]

00814386021654Temporary Fixation Screw
00814386021647Drill, 2.5 x 20mm
00814386021630Drill, 2.5 x 18mm
00814386021623Drill, 2.5 x 16mm
00814386021616Drill, 2.5 x 14mm
00814386021609Drill, 2.5 x 12mm
00814386021593Drill, 2.5 x 10mm
00814386021586Plate Holder - Inner Connection
00814386021579Awl Sleeve
008143860215622.5 Hex Screwdriver Shaft, Tapered Tip
008143860215552.5 Hex Screwdriver Shaft, Split Tip
00814386021548Jeweler Handle
00814386021531Static Handle
00814386021524Ratcheting Handle
00814386021517Plate Holder - Outer Connection
00814386021500Plate Bender
00814386021494Dual Drill Guide
00814386021487Fixed Drill Guide
00814386021470Variable Drill Guide
00814386021463Awl
00814386021456Implant Module #7 Screw Caddy - 10mm & 20mm Screws
00814386021449Implant Module #6 Screw Caddy - 4.0 Self Tapping & Self Drilling & 4.5mm
00814386021432Implant Module #5 Screw Caddy - 4.0 Combo Self Drill/Tapping & 4.5mm Screws
00814386021425Implant Module #4 - 1&2 Level Midline Plates
00814386021418Implant Module #3 - 4 Level Standard Plates
00814386021401Implant Module #2 - 3 Level Standard Plates
00814386021395Implant Module #1 - 1&2 Level Standard Plates
00814386021388Implant Tray Lid
00814386021371Implant Tray - Top Layer
00814386021364Outer Base
00814386021357Lid
00814386021340Lid Module #7 - 10mm and 20mm Screw Lengths
00814386021333Lid Module #6 - 4.0 Self-Tapping and Self-Drilling & 4.5mm Screws
00814386021326Lid Module #5 - 4.0 Combo Self Drill/Tapping & 4.5mm Screws
00814386021319Lid Module #4 - 1&2 Level Midline Plates
00814386021302Lid Module #3 - 4 Level Standard Plates
00814386021296Lid Module #2 - 3 Level Standard Plates
00814386021289Lid Module #1 - 1&2 Level Standard Plates
00814386021272Rescue Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.5x20mm
00814386021265Rescue Self-Drilling/Self-Tapping Variable Screw, Light Blue, 4.5x18mm
00814386021258Rescue Self-Drilling/Self-Tapping Variable Screw, Gold, 4.5x16mm
00814386021241Rescue Self-Drilling/Self-Tapping Variable Screw, Magenta, 4.5x14mm
00814386021234Rescue Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.5x12mm
00814386021227Rescue Self-Drilling/Self-Tapping Variable Screw, Green, 4.5x10mm
00814386021210Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.0x20mm
00814386021203Self-Drilling/Self-Tapping Variable Screw, Light Blue, 4.0x18mm
00814386021197Self-Drilling/Self-Tapping Variable Screw, Gold, 4.0x16mm
00814386021180Self-Drilling/Self-Tapping Variable Screw, Magenta, 4.0x14mm
00814386021173Self-Drilling/Self-Tapping Variable Screw, Dark Blue, 4.0x12mm
00814386021166Self-Drilling/Self-Tapping Variable Screw, Green, 4.0x10mm
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