FDA.reportPublic FDA data

ReActiv8 Release Tool

Primary DI
05391527772804
Brand
ReActiv8 Release Tool
Company
MAINSTAY MEDICAL LIMITED
Model
EXT1
Published
2024-01-22
Public version status
Update
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391527772804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391527772804053915277728045391527772804

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
985519015
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391527771357ReActiv8 Programmer 6M7500-0112025-05-22
05391527771364ReActiv8 Programmer 6M7500-0122025-05-22
05391527770626ReActiv8 Magnet6M4000-00340002021-01-25
05391527772071ReActiv8 Stimulation Lead7M8145-00681452021-01-25
05391527772279ReActiv8 Stimulation Lead7M8165-00681652021-01-25
05391527770046ReActiv8 IPG7M5100-00551002025-02-13
05391527772415Mainstay Tunneler7MTUN1-002TUN12021-01-25
05391527770633ReActiv8 Magnet6M4000-00440002021-01-25
05391527770213ReActiv8 Programming Wand6M6000-00260002021-01-25
05391527770411ReActiv8 Activator6M7000-00270002021-01-25
05391527772064ReActiv8 Stimulation Lead7M8145-00581452021-01-25
05391527772262ReActiv8 Stimulation Lead7M8165-00581652021-01-25
05391527770015ReActiv8 IPG7M5100-00251002021-01-25
05391527770817ReActiv8 Torque Wrench7M5500-00255002021-01-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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