FDA.reportPublic FDA data

Lyftee

Primary DI
90855459008106
Brand
Lyftee
Company
Stetrix, Inc.
Model
LYFY-01
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXTTape, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXTTape, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90855459008113PackageGS110In Commercial Distribution
90855459008106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9085545900811390855459008113
9085545900810690855459008106

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Regulatory Flags#

DUNS number
827509667
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855459008134Jannus Pannus RetractorPPR-182025-01-17
00855459008042Pannus Retention SystemTRS-062025-01-10
00855459008059Pannus Retention SystemTRS-082025-01-10
00855459008080Panni Retractor SystemPPR-132025-01-10
00855459008004Pannus Retention SystemTRS-042025-01-10
10855459008049Pannus Retention SystemTRS-062025-01-10
10855459008056Pannus Retention SystemTRS-082025-01-10
10855459008087Panni Retractor SystemPPR-132025-01-10
00855459008097Labor Guard Perianal StabilizerLG-012024-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855459008134Jannus Pannus RetractorStetrix, Inc.HXT2025-01-17
00855459008042Pannus Retention SystemStetrix, Inc.HXT2025-01-10
00855459008059Pannus Retention SystemStetrix, Inc.HXT2025-01-10
00855459008080Panni Retractor SystemStetrix, Inc.HXT2025-01-10
00855459008004Pannus Retention SystemStetrix, Inc.HXT2025-01-10
10855459008049Pannus Retention SystemStetrix, Inc.HXT2025-01-10
10855459008056Pannus Retention SystemStetrix, Inc.HXT2025-01-10
10855459008087Panni Retractor SystemStetrix, Inc.HXT2025-01-10
00613994966230Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00613994966292Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00613994966308Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00613994966315Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXT2022-10-17
00889024287372Anatomical Shoulderâ„¢Zimmer GmbHHXT2020-06-30
00760236206811MEIJERMEIJER, INC.HXT2020-06-22
10885403062919V. MuellerSTERIS CORPORATIONHXT2019-05-16