FDA.reportPublic FDA data

NA

Primary DI
00885554030853
Brand
NA
Company
Smith & Nephew, Inc.
Model
72200242F3E
Catalog number
72200242F3E
Device description
RFB 3RD EDITION 660IMS
Published
2023-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMBDevice, digital image storage, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885554030853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885554030853008855540308538855540308530885554030853

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008902Roentgen WorksBrit Systems, LLCLMB2026-08-27
00850631008896Roentgen WorksBrit Systems, LLCLMB2026-08-14
00850631008889Roentgen WorksBrit Systems, LLCLMB2026-08-13
00854810007229iCRco Clarity ViewerIcRco, Inc.LMB2026-07-22
00850631008872Roentgen WorksBrit Systems, LLCLMB2026-06-23
00850631008865Roentgen WorksBrit Systems, LLCLMB2026-06-05
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
00850631008834Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008841Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
04907034602476UR-4MDTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2026-01-09
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850631008797Roentgen WorksBrit Systems, LLCLMB2025-11-20
00850631008766Roentgen WorksBrit Systems, LLCLMB2025-10-01
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00850631008759Roentgen WorksBrit Systems, LLCLMB2025-08-14
00850631008742Roentgen WorksBrit Systems, LLCLMB2025-08-07
00850631008735Roentgen WorksBrit Systems, LLCLMB2025-07-31
04907034602155UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602162UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602230UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602247UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602254UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602261UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602278UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602285UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31