What is FDA product code OFG?

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.

Cardiovascular › SurgicalCt Biopsy Tray

Halyard

Name: Halyard
Brand: Halyard

Catalogue number AMCT10-01, listed by Avid Medical, Inc., United States, under Ct Biopsy Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

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

Record

Regulatory record for Halyard
Listed by	Avid Medical, Inc., United States
FDA product code	OFG
Device type	Ct Biopsy Tray
Device class	Class 2
Regulation	21 CFR 870.4075
Premarket notification	Exempt
Record published	2026-06-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Special storage condition: STORE AT ROOM TEMPERATURE
Packaging	Pack of 4
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Halyard
Catalogue number	Size	Status
AMCT10-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	1,252
Cardinal Health	Cardinal Health 200, LLC	315
Medline	Medline Industries, Inc.	37
Centurion Medical Products Corp	Medline Industries, Inc.	28
ACS	American Contract Systems, Inc.	11
Centurion	Centurion Medical Products Corporation	6
DeRoyal	Deroyal Industries, Inc.	1

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.