UL_INJECT XD 8000

GUDID 04052536002245

XD 8000, ulrichINJECT CT motion composed of:

Ulrich GmbH & Co. KG

CT contrast medium injection system, line-powered, mobile
Primary Device ID04052536002245
NIH Device Record Keybb1918ab-848f-42f7-8765-bb4881b49850
Commercial Distribution StatusIn Commercial Distribution
Brand NameUL_INJECT
Version Model NumberXD 8000
Catalog NumberXD 8000
Company DUNS315494757
Company NameUlrich GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com
Phone+4907319654152
Emailsafety@ulrichmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104052536002245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZQInjector, contrast medium, automatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-20
Device Publish Date2019-03-12

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04052536081547 - uCentum2025-08-08 Reduction arm, percutaneous, left
04052536081554 - uCentum2025-08-08 Reduction arm, percutaneous, right
04052536081561 - uCentum2025-08-08 Reduction arm, percutaneous, variable
04052536081578 - uCentum2025-08-08 Reduction wheel
04052536081622 - uCentum2025-08-08 Counterpart, open

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