BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

SAVANNAH-T

DI: 00840916150761 · Model: 10-TR-1 · SPINAL ELEMENTS

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Basic Information

Brand Name: SAVANNAH-T
Primary DI: 00840916150761
Version / Model: 10-TR-1
Company Name: SPINAL ELEMENTS
Labeler DUNS: 004022104
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-05-05
Public Version: 5
Public Version Date: 2023-04-04
Public Version Status: Update
Public Device Record Key: fc1bcbeb-1cd8-4d37-b3b5-55ca6edd987f

Device Description

SAVANNAH®-T INSTRUMENT TRAY CASE 1

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: Yes
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJH	Orthopedic Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13730	Device sterilization/disinfection container, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840916150761	GS1