What is FDA product code OJH?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General & Plastic Surgery › SurgicalOrthopedic Tray

Removal System Instrument Set

Name: Removal System Instrument Set
Brand: Removal System Instrument Set

2 catalogue numbers from 400132, listed by SI-Bone, Inc., United States, under Orthopedic Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue 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 Removal System Instrument Set
Listed by	SI-Bone, 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
Record published	2026-03-24

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

Catalogue Numbers

Catalogue numbers for Removal System Instrument Set
Catalogue number	Size	Status
400132		In distribution
400132		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.