FDA.report

Sapphire

Primary DI
00840606136457
Brand
Sapphire
Company
SPINAL ELEMENTS, INC.
Model
27107-000
Device description
SAPPHIRE® TAPERED SCREWDRIVER
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
00840606136457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606136457008406061364578406061364570840606136457

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840606174800Primus66440-0002026-03-06
00840606187138Primus66900-0002026-02-27
00840606187145Primus66900-000-012026-02-27
00840606187152Primus66900-000-022026-02-27
00840606187169Primus66900-000-032026-02-27
00840606187176Primus66900-000-042026-02-27
00840606187268Primus66900-0302026-02-27
00840606187275Primus66900-030-012026-02-27
00840606187282Primus66900-030-022026-02-27
00840606187299Primus66900-030-032026-02-27
00840606187305Primus66900-030-042026-02-27
00840606187312Primus66900-030-052026-02-27
00840606187329Primus66900-030-062026-02-27
00840606187336Primus66900-030-072026-02-27
00840606187343Primus66900-030-082026-02-27
00840606187367Primus66900-030-092026-02-27
00840606185172Primus66430-0182026-01-23
00840606185189Primus66430-0242026-01-23
00840606185196Primus66430-1182026-01-23
00840606185202Primus66430-1242026-01-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00191072241979ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
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
00869397000013XL Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000020Radiolucent Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000037Standard Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000044Removal System Instrument SetSi-Bone Inc.OJH2026-03-24
008693970000517.5mm & 10.75mm Instrument SetSi-Bone Inc.OJH2026-03-24
50198956278484CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956302929CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956307986CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956308006CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956357981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956360530CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956362015CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956366372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956372472CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956377804CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956382600CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956387438CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956409819CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956415186CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956425697CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426397CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426762CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956427394CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956429312CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24