Sapphire

Sapphire® Implants & Instruments Tray, Three Level Plate Caddy, Base

Registry build 21.09.26
1manufacturer
76catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJH
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Record

Regulatory record for Sapphire
Listed by Spinal Elements, Inc., United States
FDA product code OJH
Device type Orthopedic Tray
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-12-04
Record revised 2023-05-03 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Sapphire
Catalogue number Size Status
26033-003 In distribution
26167-000 In distribution
26000-002-76 In distribution
26076-000 In distribution
26075-000 In distribution
26000-000-05 In distribution
26166-000 In distribution
26000-002-26 In distribution
26165-000 In distribution
26000-002-21 In distribution
26000-002-27 In distribution
26000-000-01 In distribution
26086-012 In distribution
26085-014 In distribution
26101-000 In distribution
26066-000 In distribution
27050-000 In distribution
26172-000 In distribution
27000-000-01 In distribution
26030-000 In distribution
26115-000 In distribution
26000-002-34 In distribution
26032-000 In distribution
26085-010 In distribution
26000-002-33 In distribution
26000-002-17 In distribution
26000-002-16 In distribution
26000-002-11 In distribution
26055-000 In distribution
26050-000 In distribution
27107-000 In distribution
26065-000 In distribution
26025-000 In distribution
26000-002-77 In distribution
26000-000 In distribution
26000-002-32 In distribution
26000-002-22 In distribution
26000-002-31 In distribution
26061-000 In distribution
26080-000 In distribution
26000-002-25 In distribution
26086-016 In distribution
26091-014 In distribution
26000-002-35 In distribution
27000-000-06 In distribution
26170-000 In distribution
26000-002-15 In distribution
26105-000 In distribution
26085-016 In distribution
26000-002-10 In distribution
26000-000-20 In distribution
26051-000 In distribution
26031-000 In distribution
26086-010 In distribution
27101-001 In distribution
27000-000-05 In distribution
26102-000 In distribution
26000-000-04 In distribution
27000-000-02 In distribution
26000-002-71 In distribution
26100-000 In distribution
26070-000 In distribution
26171-000 In distribution
26086-014 In distribution
26000-000-02 In distribution
27101-002 In distribution
26000-002-72 In distribution
27000-000-04 In distribution
27000-000-03 In distribution
26000-002-12 In distribution
26000-002-20 In distribution
26085-012 In distribution
26000-002-30 In distribution
26060-000 In distribution
26090-010 In distribution
26000-000-03 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 95,039
Medline Industries, Inc. Medline Industries, Inc. 53,097
Avid TruCustom Avid Medical, Inc. 3,990
ACS American Contract Systems, Inc. 3,812
Halyard Avid Medical, Inc. 1,313
Aligned Medical Solutions Aligned Medical Solutions 1,272
Regard™ ROi CPS LLC 464
Overwatch Spinal Elements, Inc. 223
Regard™ Resource Optimization & Innovation, L.L.C. 191
Lucent L Spinal Elements, Inc. 95
Invenio GRI Medical & Electronic Technology Co., Ltd. 87
Integra® Ascension Orthopedics, Inc. 81

Showing 12 of 367. All products under Orthopedic Tray

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer