FDA.reportPublic FDA data

uCentum

Primary DI
04052536216161
Brand
uCentum
Company
Ulrich GmbH & Co. KG
Model
CS 3823-100
Device description
Awl, cannulated, for screws Ø 10.0 mm, coupling A
Published
2026-03-31
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
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536081134PreviousGS10
04052536216161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536081134040525360811344052536081134
04052536216161040525362161614052536216161

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
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
04052536078349neon3CS 71502026-06-09
04052536078356neon3CS 71522026-06-09
04052536078363neon3CS 71542026-06-09
04052536123728mamboCS 71342026-06-09
04052536163403neon3CS 3994-002-0002026-06-09
04052536163410neon3CS 3994-001-0002026-06-09
04052536163434neon3CS 3994-003-0002026-06-09
04052536164585neon3CS 3994-001-0012026-06-09
04052536164592neon3CS 3994-001-0022026-06-09
04052536164608neon3CS 3994-001-0032026-06-09
04052536169931neon3CS 71552026-06-09
04052536177516neon3CS 7040-652026-06-09
04052536218073uCentumUL 8526-232026-06-09
04052536218080uCentumUL 8527-232026-06-09
04052536221202uCentumCS 7020-62026-06-09
04052536221219uCentumCS 7040-42026-06-09
04052536221233uCentumCS 7040-62026-06-09
04052536085651neon3CS 39412026-06-08
04052536085668neon3CS 39422026-06-08
04052536161997neon3CS 3940-012026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076482Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03
00199150076499Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03
00840606191586Overwatch PCFSPINAL ELEMENTS, INC.HWJ2026-07-31
00763000879556MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-07-19
18257200051175PROVIEWOrthofix US LLCHWJ2026-07-17
18257200163571PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163588PILLAR SA TiOrthofix US LLCHWJ2026-07-17
18257200163595PILLAR SA TiOrthofix US LLCHWJ2026-07-17
B8034609130ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609140ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609150ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034609160ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803030ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803360ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803370ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803380ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803390ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803400ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
B8034803410ORTHOMEDORTHO-MED, INC.HWJ2026-07-16
00857915007767IM Nail AwlA.M. SURGICAL, INC.HWJ2026-06-10
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
08800322758137Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWJ2026-04-21
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21