Mark-through GuideLines

CT Grid for Localizing Needle Entry Sites, 6.25x6.75" biopsy grid

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code IXJ
Manufacturer City Province Registered as Device types
Guangzhou Bioway Medical Technology Joint-Stock Co., Ltd. Guangzhou Guangdong Manufacturer 8

Record

Regulatory record for Mark-through GuideLines
Listed by Beekley Corporation, United States
FDA product code IXJ
Device type Grid, Radiographic
Device class Class 1
Regulation 21 CFR 892.1910
Establishment Manufacturer
Premarket notification Exempt
Record published 2019-07-22
Record revised 2024-08-30 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Distribution end date 2024-08-29

Catalogue Numbers

Catalogue numbers for Mark-through GuideLines
Catalogue number Size Per pack Status
219 15 Withdrawn
219S 2 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MS X-RAY Grid Mitaya Manufacturing Co., Ltd. 153
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Grid, Radiographic Samsung Electronics Co., Ltd. 7
GuideLines Beekley Corporation 4
True Speed Bucky Carestream Health, Inc. 3
MS-LD Grid Mitaya Manufacturing Co., Ltd. 3
Radiographic grid JPI Healthcare Co., Ltd. 3
Grid Facile Mitaya Manufacturing Co., Ltd. 3
Grid Landscape for SkyPlate large Philips Medical Systems DMC GmbH 3
Grid Portrait for SkyPlate large Philips Medical Systems DMC GmbH 3
X-Ray Grid 40/8/110 Philips Medical Systems DMC GmbH 2
Directview CR Gridded Cassette with PQ Screen Carestream Health, Inc. 2

Showing 12 of 70. All products under Grid, Radiographic

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer