FDA.reportPublic FDA data

SAVANNAH

Primary DI
00840916160760
Brand
SAVANNAH
Company
SPINAL ELEMENTS
Model
SP-0230
Device description
SAVANNAH®-T LOW TOP TRAY (SPECIAL)
Published
2021-01-16
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916160760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916160760008409161607608409161607600840916160760

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916123710ZEUS-T67-2811122017-08-01
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916142926ZEUS-O101122021-01-11
00840916143008ZEUS-O109972021-01-11
00840916160135SPARTAN103132020-12-07
00840916156947ZEUS-O105002020-05-11
00840916117603SLPSS82192017-08-10
00840916149840SAVANNAH91052020-04-16
00840916150143SAVANNAH82712020-04-16
00840916150150SAVANNAH90012020-04-16
00840916150167SAVANNAH90022020-04-16
00840916150174SAVANNAH90042020-04-16
00840916150211SAVANNAH90502020-04-16
00840916150228SAVANNAH90902020-04-16
00840916115555SAMSON135142017-08-01
00840916115562SAMSON135152017-08-01
00840916115579SAMSON135162017-08-01
00840916115586SAMSON135172017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS199160Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199340Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199930Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS6160F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9487F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9509E0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
10198956374232CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956400801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956424654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956486645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
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10198956559646CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560598CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956561212CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25