FDA.reportPublic FDA data

Arcadia™

Primary DI
10884450447342
Brand
Arcadia™
Company
Merit Medical Systems, Inc.
Model
00884450447345
Catalog number
ARC25SB
Published
2020-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191596000Arcadia Balloon CatheterMerit Medical Systems, Inc.2019-10-09HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450447342PackageGS116In Commercial Distribution
00884450447345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445044734210884450447342
00884450447345008844504473458844504473450884450447345

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable bone tampA catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
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
true
Expiration date on label
true
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
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31
00884450500927Merit Medical®Initial ReleaseK12T-02563D2026-08-01
00884450838136Prelude Roadster™APG6F45R2026-07-31
00884450117156Merit Medical®Initial ReleaseK12T-03663D2026-07-30
00884450486191Merit Medical®Initial ReleaseK12T-12644C2026-07-30
00884450486207Merit Medical®Initial ReleaseK12T-12645C2026-07-30
00884450498996Merit Medical®Initial ReleaseK09-143912026-07-30
00884450499207Merit Medical®Initial ReleaseK10T-01528J2026-07-30
00884450587713StabiliT®DDF-5000A2026-07-30
00884450022146One-Step™DOSC-4F-10LT2026-07-29
00884450022160One-Step™DOSC-4F-10T2026-07-29
00884450022184One-Step™DOSC-4F-7LT2026-07-29
00884450022306One-Step™DOSC-4F-7T2026-07-29
00884450022313One-Step™DOSC-5F-10LT2026-07-29
00884450022535One-Step™DOSC-5F-7LT2026-07-29
00884450022559One-Step™DOSC-5F-10S2026-07-29
00884450022566One-Step™DOSC-5F-7S2026-07-29
00884450022573One-Step™DOSC-4F-10L2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
10845854035559E9000Conmed CorporationHRX2026-03-24
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
B235MDK00020mild Device KitSTRYKER CORPORATIONHRX2024-06-19
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25