FDA.report

Sapphire

Primary DI
00840606136303
Brand
Sapphire
Company
SPINAL ELEMENTS, INC.
Model
26115-000
Device description
SAPPHIRE® BREAKAWAY DRIVER
Published
2019-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OJHOrthopedic Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840606136303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606136303008406061363038406061363030840606136303

GMDN Terms

TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
610712213
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

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Other Devices Sharing Product Codes

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00191072241986ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241993ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242006ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242013ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242020ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
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00869397000044Removal System Instrument SetSi-Bone Inc.OJH2026-03-24
008693970000517.5mm & 10.75mm Instrument SetSi-Bone Inc.OJH2026-03-24
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