What is FDA product code OJG?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.

Neurology › SurgicalNeurological Tray

V. Mueller

Name: V. Mueller
Brand: V. Mueller

V. Mueller Neuro/Spine HUMAN TRIAL INST- NOT FOR SALE CLEANACCESS KERRISON RONGEUR NON-COATED MICRO HANDLE 1-5MM BITE, LENG 10 inches, 10MM OPN

Registry build 21.09.26

1manufacturer

27catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

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

Record

Regulatory record for V. Mueller
Listed by	Steris Corporation, United States
FDA product code	OJG
Device type	Neurological Tray
Device class	Class 1
Regulation	21 CFR 882.4525
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2018-02-05
Record revised	2024-11-07 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Distribution end date	2024-11-06
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for V. Mueller
Catalogue number	Size	Status
CLIISET2		In distribution
S-TAKER8SS		In distribution
TCOATSET7		In distribution
S-TAKER12SS		In distribution
CLIISET7		In distribution
SM-0162		In distribution
OS5000		In distribution
TCOATSET4		In distribution
CLIISET6		In distribution
TCOATSET3		In distribution
TCOATSET1		In distribution
S-TAKER7SS		In distribution
S-TAKER10SS		In distribution
TCOATSET6		In distribution
SM-0160		In distribution
TCOATSET2		In distribution
CLIISET3		In distribution
S-TAKER7T		In distribution
NL9700S		In distribution
S-TAKER10SS0		In distribution
CLIISET5		In distribution
CLIISET1		In distribution
CLIISET4		In distribution
TCOATSET5		In distribution
S-TAKER12T		Withdrawn
S-TAKER8T		Withdrawn
S-TAKER10T		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	25,194
Medline Industries, Inc.	Medline Industries, Inc.	3,084
Avid TruCustom	Avid Medical, Inc.	969
ACS	American Contract Systems, Inc.	938
Halyard	Avid Medical, Inc.	718
Regard™	ROi CPS LLC	208
Regard™	Resource Optimization & Innovation, L.L.C.	55
Aligned Medical Solutions	Aligned Medical Solutions	53
Nico BrainPath Approach	Nico Corporation	25
V. Mueller	Carefusion 2200, Inc.	13
Invenio	GRI Medical & Electronic Technology Co., Ltd.	11
Phasor	Phasor Health, LLC	8

Showing 12 of 24. All products under Neurological 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.