FDA.reportPublic FDA data

Decima Spine Instrument Kit

Primary DI
00857360007138
Brand
Decima Spine Instrument Kit
Company
DECIMA SPINE, INC.
Model
6139
Catalog number
6139
Device description
Decima Spine Instrument Kit, Tray Assembly
Published
2018-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00857360007138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857360007138008573600071388573600071380857360007138

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (954) 243-6103carlos@decimaspine.com

Regulatory Flags#

DUNS number
080963983
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857360007176FCD-2 IMPLANT SYSTEM90629062-002018-04-08
00857360007190FCD-2 IMPLANT SYSTEM90639063-002018-04-08
00857360007060Decima Spine Instrument Kit609560952018-04-04
00857360007213Decima Spine Instrument Kit613461342018-04-08
00857360007114Decima Spine Instrument Kit612861282018-04-08
00857360007206Decima Spine Instrument Kit615861582018-04-08
00857360007053Decima Spine Instrument Kit609460942018-04-04
00857360007077Decima Spine Instrument Kit609660962018-04-04
00857360007015Decima Spine Instrument Kit607960792018-04-04
00857360007008Decima Spine Instrument Kit6072-006072-002018-04-08
00857360007084Decima Spine Instrument Kit611861182018-04-08
00857360007091Decima Spine Instrument Kit611961192018-04-08
00857360007107Decima Spine Instrument Kit612061202018-04-08
00857360007145Decima Spine Instrument Kit9061-009061-002018-04-08
00857360007220Decima Spine Instrument Kit9067-009067-002018-04-08
00857360007039Decima Spine Instrument Kit6086-016086-012018-04-04
00857360007046Decima Spine Instrument Kit609360932018-04-04

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Primary DI, Brand, Company table
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