What is FDA product code OIJ?

FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturers device is exempt from the pr

Radiology › DiagnosticBiopsy Needle Guide Kit

Sheathes

Name: Sheathes
Brand: Sheathes

Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face to 15.2cm x 244cm) Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics,…

Registry build 21.09.26

Seamless Viral Barrier Box End, Polyurethane, 1″ x 3.2″ Face to 6″W x 96″L (2.5cm x 8.1cm Face to 15.2cm x 244cm) Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5 & 2.0cm) & Adapter, Tilt-Out Style

4manufacturers in China registered for this device type

14catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code OIJ
Manufacturer	City	Province	Registered as	Device types
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46
Sonoscape Medical Corp.	Shenzhen	Guangdong	Manufacturer	7
Shenzhen Wisonic Medical Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4
Jingfang Precision Medical Device(Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	1

Record

Regulatory record for Sheathes
Listed by	Sheathing Technologies, Inc., United States
FDA product code	OIJ
Device type	Biopsy Needle Guide Kit
Device class	Class 2
Regulation	21 CFR 892.1560
Establishment	Repacker / relabeller, Manufacturer
Record published	2020-12-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Case of 3

Catalogue Numbers

Catalogue numbers for Sheathes
Catalogue number	Per pack	Status
65-966-12110-3	10	In distribution
65-486-22005-4	10	In distribution
65-486-12110-3	10	In distribution
65-485-12110-3	10	In distribution
65-IL966-22110-3	10	In distribution
65-966-22005-4	10	In distribution
65-484-22110-3	10	In distribution
65-486-22110-3	10	In distribution
65-966-21815-3	10	In distribution
65-486-21815-3	10	In distribution
65-486-11815-3	10	In distribution
65-966-22110-3	10	In distribution
65-966-11815-3	10	In distribution
65-484-21815-3	10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
InnoFine	Jingfang Precision Medical Device(Shenzhen) Co., Ltd.	531
SonoScape	Sonoscape Medical Corp.	70
Hitachi	Hitachi, Ltd.	57
Mindray	Jingfang Precision Medical Device(Shenzhen) Co., Ltd.	16
Cardinal Health	Cardinal Health 200, LLC	12
Sheathes3D	Sheathing Technologies, Inc.	7
iSR’obot Kit	Biobot Surgical Pte. Ltd.	4
NGB-007 Needle-guided Bracket	Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	2
NGB-011 Needle-guided Bracket	Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	2
NGB-022 Needle-guided Bracket	Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	2
NGB-018 Needle-guided Bracket	Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	2
Moving-Shot Guide	RF Medical Co., Ltd.	2

Showing 12 of 45. All products under Biopsy Needle Guide Kit

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.