What is FDA product code ORG?

Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.

Hematology › Blood Establishment ProductsPlatelet And Plasma Separator For Bone Graft Handling

Intra-Lock

Name: Intra-Lock
Brand: Intra-Lock

L-PRF Red Cap Blood Collection CAT Tube (9 ml)

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1).

Chinese manufacturers registered for FDA product code ORG
Manufacturer	City	Province	Registered as	Device types
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Beijing Hanbaihan Medical Devices Co., Ltd.	Beijing	Beijing	Contract manufacturer	4

Record

Regulatory record for Intra-Lock
Listed by	Intra-Lock International, United States
FDA product code	ORG
Device type	Platelet And Plasma Separator For Bone Graft Handling
Device class	Class 2
Regulation	21 CFR 864.9245
510(k)	BK120048
Record published	2020-07-29

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Intra-Lock
Catalogue number	Size	Status
WCT_50		In distribution
BVBCTP2_50		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arthrex®	Arthrex, Inc.	30
Endoret KIT	Biotechnology Institute SL	14
Harvest®	Terumo BCT, Inc..	14
IntraSpin	Intra-Lock International	13
Xcell	Apex Biologix	13
BioHorizons	Biohorizons Implant Systems Inc.	11
Celling ART PRP System	Celling Biosciences	8
Progen PRP Eclipse	Bellus Medical, LLC	8
Selphyl®	Factor Medical Inc.	7
Tropocells	Estar Technologies Ltd.	7
Virtue ACKit	Aeon Biotherapeutics Corp.	7
Aeon ACKit	Aeon Biotherapeutics Corp.	6

Showing 12 of 119. All products under Platelet And Plasma Separator For Bone Graft Handling

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.