FDA.reportPublic FDA data

S120 Sterilization Tray

Primary DI
07630055505743
Brand
S120 Sterilization Tray
Company
Bien-Air Surgery SA
Model
1600828
Catalog number
1600828-001
Published
2023-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MMOTray, Surgical, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055505743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055505743076300555057437630055505743

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481597719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27630055509653Long Microsaw Blade 32x0.4mm 15026791502679-0012026-04-21
27630055517672Left Inferior Boarder Osteotomy Blade15027231502723-0012026-04-21
47630055517676Left Inferior Boarder Osteotomy Blade15027231502723-0102026-04-21
27630055509479Short Microsaw Blade 22x0.4mm15026711502671-0012026-04-21
27630055509585Short Microsaw Blade 27x0.4mm15026721502672-0012026-04-21
27630055509592Short Microsaw Blade 32x0.4mm15026731502673-0012026-04-21
27630055509608Short Microsaw Blade 22x0.6mm15026741502674-0012026-04-21
27630055509615Short Microsaw Blade 27x0.6mm15026751502675-0012026-04-21
27630055509622Short Microsaw Blade 32x0.6mm15026761502676-0012026-04-21
27630055509639Long Microsaw Blade 22x0.4mm15026771502677-0012026-04-21
27630055509646Long Microsaw Blade 27x0.4mm15026781502678-0012026-04-21
27630055509660Long Microsaw Blade 22x0.6mm15026801502680-0012026-04-21
27630055509677Long Microsaw Blade 27x0.6mm15026811502681-0012026-04-21
27630055509684Long Microsaw Blade 32x0.6mm15026821502682-0012026-04-21
27630055517641Right Inferior Boarder Osteotomy Blade15027221502722-0012026-04-21
27630055517702Short Oscillating Blade 6x0.4mm15027241502724-0012026-04-21
27630055517733Short Oscillating Blade 9x0.4mm15027251502725-0012026-04-21
27630055517764Long Oscillating Blade 6x0.4mm15027261502726-0012026-04-21
27630055517795Long Oscillating Blade 9x0.4mm15027271502727-0012026-04-21
27630055517825Short Sagittal Blade 6x0.4mm15027431502743-0012026-04-21

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