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
Rx
false
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
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
00857534006868IMRISmatrix 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
04907034602308UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602315UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602322UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602339UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602346UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602353UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602377UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602384UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602391UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602407UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602445UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602452UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31