Who else makes this device?

Name: Half Blue X-ray Film WB
Brand: Half Blue X-ray Film WB

Half Blue X-Ray Film WB · Film, Radiographic → Radiology

3manufacturers in China registered for this device type

7catalogue numbers in this listing

6recalls on this code

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code IWZ
Manufacturer	City	Province	Registered as	Device types
Rayco (Xiamen) Medical Products Company Limited	Xiamen	Fujian	Contract manufacturer	1
Zogear Medical Co., Ltd.	Yizheng	Jiangsu	Contract manufacturer	75
Shanghai Alwings Medical Instrument Co., Ltd.	Shanghai	Shanghai	Manufacturer	39

Record

Regulatory record for Half Blue X-ray Film WB
Listed by	Carestream Health, Inc., United States
FDA product code	IWZ
Device type	Film, Radiographic
Device class	Class 1
Regulation	21 CFR 892.1840
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-16
Record revised	2021-05-14 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number
Storage	Handling environment humidity 30 to 60 % RH; Handling environment temperature 4 to 25 °C; Storage environment humidity 30 to 60 % RH; Storage environment temperature 4 to 25 °C
Packaging	Case of 5
Distribution end date	2021-05-12

Catalogue Numbers

Catalogue numbers for Half Blue X-ray Film WB
Catalogue number	Per pack	Status
Half Blue X-ray Film WB	25	In distribution
Half Blue X-ray Film WB	100	In distribution
Half Blue X-ray Film WB	100	In distribution
HALF Blue X-ray Film WB	100	In distribution
Half Blue X-ray Film WB	100	Withdrawn
Half Blue X-ray Film WB	100	Withdrawn
Half Blue X-ray Film WB	100	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Gafchromic™	Ashland Specialty Ingredients, G.P.	151
Dryview DVB Laser Imaging Film	Carestream Health, Inc.	42
Imaging Plates	Palodex Group OY	24
Henry Schein	Henry Schein, Inc.	24
Fuji Medical X-RAY Film	Fujifilm Corporation	21
Ultra-speed	Carestream Health, Inc.	17
T-MAT G/RA Film	Carestream Health, Inc.	16
Dryview DVM Mammography Laser Imaging Film	Carestream Health, Inc.	16
E Blue X-ray Film WB	Carestream Health, Inc.	15
Medical X-ray Green / MXG Film	Carestream Health, Inc.	15
Rad Control	Typenex Medical, LLC	15
Insight	Carestream Health, Inc.	15

Showing 12 of 259. All products under Film, Radiographic

Recalls

3 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-07-02	Class III	Package design/selection	The Indicator Dot on the film packet’s outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed	1633 boxes	2016-05-25
2014-07-02	Class III	Package design/selection	The Indicator Dot on the film packet’s outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed	1633 boxes	2016-05-25
2013-01-17	Class III	Process change control	Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol	101 cartons: Domestic – 95 cartons; Foreign – 6 cartons	2016-05-18
2011-12-20	Not classified	Nonconforming Material/Component	Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.	24 cartridges	2016-05-17
2010-03-12	Not classified	Mixed-up of materials/components	Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.	875 boxes	2010-07-07
2010-03-12	Not classified	Mixed-up of materials/components	Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.	560 boxes	2010-07-07

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.

Half Blue X-Ray Film WB