FDA.reportPublic FDA data

Sterilization Tray Trauma / Knee Arthroscopy

Primary DI
04056481122904
Brand
Sterilization Tray Trauma / Knee Arthroscopy
Company
Brainlab SE
Model
52300
Published
2020-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481122904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481122904040564811229044056481122904

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental 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 or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Regulatory Flags#

DUNS number
314482980
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147099Buzz O.R. Compute179222026-07-09
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
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
00840606192002Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192019Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192026Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192033Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192040Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194884Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194891Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194907Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194914Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194921Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194938Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194945Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194952Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194969Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194976Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194983Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194990Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195003Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195010Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195027Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195034Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195041Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195058Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195065Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195539Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195669Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195676Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195683Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195690Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195706Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31