OTIS-F EVO9080000

GUDID 03760154009485

OTIS-F cleaning and sterilization basket.

S.B.M

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID03760154009485
NIH Device Record Keyf2c0b860-b41d-4150-be73-5e9e117e0de4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTIS-F
Version Model NumberCleaning and sterilization basket
Catalog NumberEVO9080000
Company DUNS772462123
Company NameS.B.M
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154009485 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


[03760154009485]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-29
Device Publish Date2023-12-21

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03760154002578 - LIGAFIX2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction.
03760154002608 - LIGAFIX2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X5, for ACL reconstruction.
03760154002615 - LIGAFIX2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X10, for ACL reconstruction.
03760154002622 - LIGAFIX2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X1, for ACL reconstruction.
03760154002639 - LIGAFIX2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.

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