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 COLLIS TAYLOR RETRACTOR REGULAR WIDTH SET OF 6 BLADES OVERALL LENGTH 7-1/4" (18.4CM)

Registry build 21.09.26

1manufacturer

13catalogue 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	Carefusion 2200, Inc., United States
FDA product code	OJG
Device type	Neurological Tray
Device class	Class 1
Regulation	21 CFR 882.4525
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-23
Record revised	2022-03-09 (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
Distribution end date	2021-09-15
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for V. Mueller
Catalogue number	Size	Status
Z-0162		Withdrawn
Z-0162G		Withdrawn
FMLIKSET1		Withdrawn
Z-0160		Withdrawn
FMLIKSET4		Withdrawn
NL9402		Withdrawn
NL9401		Withdrawn
FMLIKSET2		Withdrawn
Z-0161		Withdrawn
FMLIKSET3		Withdrawn
NL9700-N		Withdrawn
NL9700-UN		Withdrawn
NL9700-1		Withdrawn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
V. Mueller	Steris Corporation	27
Nico BrainPath Approach	Nico Corporation	25
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.