FDA.reportPublic FDA data

UpLinq

Primary DI
00862894000319
Brand
UpLinq
Company
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
Model
UP_001
Device description
Client site located software application that receives IAD-generated data and provides the mechanism by which patient information is transferred to the Application Server (UltraLinq) via internet.
Published
2021-06-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143176000UltraLinqUltralinq Healthcare Solutions, Inc.2015-07-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862894000319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862894000319008628940003198628940003190862894000319

Contacts#

Phone, Email table
PhoneEmail
1-800-227-2956support@ultralinq.com

Regulatory Flags#

DUNS number
830536756
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00862894000302UltraLinq58.132016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20