FDA.reportPublic FDA data

Sterilization Tray Instruments Trauma

Primary DI
04056481122829
Brand
Sterilization Tray Instruments Trauma
Company
Brainlab SE
Model
52308
Published
2020-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252562000Spine & Trauma Navigation InstrumentsBrainlab AG2025-09-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481122829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481122829040564811228294056481122829

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49899915680contact@brainlab.com

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481122751Sterilization Tray Standards Cranial Accessories523152020-10-21
04056481122867Sterilization Tray Frameless Biopsy System523042020-10-21
04056481122874Sterilization Tray Varioguide523032020-10-21
04056481095406STERILIZATION TRAY SPINE BASIC/ANT/UNIV52306A52306A2020-04-02
04056481122812STERILIZATION TRAY HIP REPLACEMENT52309523092020-04-02
04056481122904Sterilization Tray Trauma / Knee Arthroscopy523002020-01-31
04056481122805Sterilization Tray Hip Resurfacing52310523102019-09-27
04056481004835Em Sterilization Tray Basic Instruments18099-08A18099-08A2016-09-15
04056481002718Headband Reference Star - Connector41877-1041877-102016-09-15
04056481003715Mscope Adapter Hs/Moeller Hi-R 700/100041767-8541767-852016-09-15
04056481141363CRANIAL 4PI CT TABLE OVERLAY434302022-05-31
04056481006884ELEMENTS LEAD LOCALIZATION1.026338-022016-11-18
04056481131920Registr. Matrix Imri Ge Headholder19202C19202C2016-09-17
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481144609ExacTrac Dynamic 2.02025-02-19
04056481144654Viewer 5.45.42024-11-05
04056481004101Target Positioner Leksell40700-20A40700-20A2016-09-15
04056481006525Em Disposable Stylet18097180972018-02-08
04056481138769Elements Trajectory Planning2.026250-02C2017-06-14
04056481141981HIP77.02020-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02