FDA.reportPublic FDA data

uCentum

Primary DI
04052536078271
Brand
uCentum
Company
Ulrich GmbH & Co. KG
Model
CS 7140
Device description
T-handle with ratchet, coupling A
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536078271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536078271040525360782714052536078271

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+ 4973196540safety@ulrichmedical.com

Regulatory Flags#

DUNS number
315494757
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536085330neon3CS 3922-4102026-05-28
04052536085361neon3CS 3924-4102026-05-28
04052536085491neon3CS 39302026-05-28
04052536085507neon3CS 39312026-05-28
04052536085552neon3CS 39342026-05-28
04052536161836neon3CS 3926-032026-05-28
04052536161867neon3CS 3927-032026-05-28
04052536161959neon3CS 3936-012026-05-28
04052536161966neon3CS 3937-032026-05-28
04052536161973neon3CS 3937-042026-05-28
04052536161775neon3CS 3920-012026-05-26
04052536216710neon3CS 3921-012026-05-26
04052536085323N/ACS 3921-02CS 3921-022016-09-22
04052536085347N/ACS 3923-01CS 3923-012016-09-22
04052536085354N/ACS 3923-02CS 3923-022016-09-22
04052536085460N/ACS 3929-02CS 3929-022016-09-22
04052536085484N/ACS 3929-04CS 3929-042016-09-22
04052536085521N/ACS 3932-02CS 3932-022016-09-22
04052536085545N/ACS 3933CS 39332016-09-22
04052536161782neon³ CT spinal stabilizationCS 3925-01CS 3925-012016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488153Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
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10649111062698Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-11
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10649111066344Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
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10649111077661Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-21