FDA.reportPublic FDA data

CORE Shoulder System

Primary DI
00810022403112
Brand
CORE Shoulder System
Company
Link Bio Corp
Model
87-9138
Device description
Stand/Cart for Workstation
Published
2025-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810022403112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022403112008100224031128100224031120810022403112

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tray standA mobile, freestanding device intended to be used during a surgical procedure onto/into which a surgical tray (e.g., surgical sponge-counting tray) can be placed. It consists of a metal vertical upright on a wheeled base with a top surface that may allow for integration of dedicated surgical trays. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
827608774
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810022403020LinkBio Instrument87-14012023-03-28
00810022403037LinkBio Instrument87-14022023-03-28
00810022403044LinkBio Instrument87-14032023-03-28
00810022402986LinkBio Instrument87-1912/012022-06-10
00810022402993LinkBio Instrument87-1912/022022-06-10
00810022403006LinkBio Instrument87-1912/032022-06-10
00810022403013LinkBio Instrument87-1912/042022-06-10
00810022403051CORE Shoulder System87-91312025-06-04
00810022403068CORE Shoulder System87-91322025-06-04
00810022403082CORE Shoulder System87-91392025-06-04
00810022403099CORE Shoulder System87-91362025-06-04
00810022403105CORE Shoulder System87-91372025-06-04
00810022403129CORE Shoulder System87-9133/16L2025-06-04
00810022403136CORE Shoulder System87-9133/20L2025-06-04
00810022403143CORE Shoulder System87-9133/24L2025-06-04
00810022403150CORE Shoulder System87-9133/28L2025-06-04
00810022403167CORE Shoulder System87-9133/16R2025-06-04
00810022403174CORE Shoulder System87-9133/20R2025-06-04
00810022403181CORE Shoulder System87-9133/24R2025-06-04
00810022403198CORE Shoulder System87-9133/28R2025-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005471PryorPRYOR PRODUCTSFOX2026-05-31
04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012409690Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012416728Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
04260217220158chapot® table System Siemens Artis zee / Q / Q.zenAmtrion GmbHFOX2026-03-30
04260217220196chapot® table System Siemens ARTIS pheno / iconoAmtrion GmbHFOX2026-03-30
09420012405999Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
09420012406019Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
09420012425805Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18