FDA.reportPublic FDA data

uCentum

Primary DI
04052536052912
Brand
uCentum
Company
Ulrich GmbH & Co. KG
Model
UL 8525-23
Device description
Pedicle probe with ball handle, lumbar, curved length 230 mm
Published
2025-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536052912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536052912040525360529124052536052912

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
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536078264uCentumCS 71382025-08-01
04052536078271uCentumCS 71402025-08-01
04052536078295uCentumCS 71442025-08-01
04052536176823N/ACS 3993-900CS 3993-9002019-05-21
04052536164417N/ACS 3995-003-000CS 3995-003-0002018-02-14
04052536164530N/ACS 3995-002-000CS 3995-002-0002018-02-14
04052536164547N/ACS 3995-001-000CS 3995-001-0002018-02-14
04052536164554N/ACS 3995-001-001CS 3995-001-0012018-02-14
04052536164615N/ACS 3994-001-004CS 3994-001-0042018-02-14
04052536164622N/ACS 3995-001-002CS 3995-001-0022018-02-14
04052536085620N/ACS 3938-03CS 3938-032016-09-22
04052536085705N/ACS 3944-02CS 3944-022016-09-22
04052536085781N/ACS 3952-01CS 3952-012018-02-14
04052536085798N/ACS 3952-02CS 3952-022018-02-14
04052536085811N/ACS 3954-01CS 3954-012018-02-14
04052536085866N/ACS 3961CS 39612016-09-22
04052536161980N/ACS 3939-01CS 3939-012016-09-22
04052536162024N/ACS 3944-03CS 3944-032016-09-22
04052536162031N/ACS 3945-01CS 3945-012016-09-22
04052536162055N/ACS 3954-03CS 3954-032018-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536161959neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161966neon3Ulrich GmbH & Co. KGHTD2026-05-28
04052536161973neon3Ulrich GmbH & Co. KGHTD2026-05-28
D9282000201SUL0SMITH SAGGITAL SPLITTER-MODW.H. Holden, Inc.HTD2026-05-27
G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
G4250601350My MedicalMy Medical Store LLCHTD2026-05-04
G4250602970My MedicalMy Medical Store LLCHTD2026-05-04
G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04
G8142900SFPP3Garish ApparelsGARISH APPARELSHTD2026-04-28
09348811015402INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-21
09348811012678INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012722INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012913INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811013163INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811014603INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811129345INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
G586UR6201390Novo SurgicalNOVO SURGICAL, INC.HTD2024-07-23
10195327656256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-07-10
10195327621100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-02-05
G508RSCMD4700Raw Surgical CorporationRAW SURGICAL CORPORATIONHTD2023-11-19
G1413040800Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040820Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040840Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G25003003120Halsted Mosquito Forceps 12.5cm StraightN S SURGICAL COMPANYHTD2023-01-31
G25003004120Halsted Mosquito Forceps 12.5cm CurvedN S SURGICAL COMPANYHTD2023-01-31
G25003051180Standard Tube Forceps 18cmN S SURGICAL COMPANYHTD2023-01-30
G25003052180Foerster Sponge Forceps 18cm StraightN S SURGICAL COMPANYHTD2023-01-30