FDA.reportPublic FDA data

N/A

Primary DI
00193982517618
Brand
N/A
Company
GLOBUS MEDICAL, INC.
Model
6142.8785
Device description
Medial Blade, 50-60mm
Published
2023-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00193982517618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982517618001939825176181939825176180193982517618

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, reusableA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
139105691
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982572983CREO6120.50866120.50862026-06-10
00193982586393CAPTIVATE3188.25113188.25112026-06-10
00193982586416CAPTIVATE3188.25133188.25132026-06-10
00193982586430CAPTIVATE3188.25153188.25152026-06-10
00193982586454CAPTIVATE3188.25173188.25172026-06-10
00193982586478CAPTIVATE3188.25193188.25192026-06-10
00193982586690CAPTIVATE3188.26143188.26142026-06-10
00193982586706CAPTIVATE3188.26153188.26152026-06-10
00193982586713CAPTIVATE3188.26163188.26162026-06-10
00193982586720CAPTIVATE3188.26173188.26172026-06-10
00193982586737CAPTIVATE3188.26183188.26182026-06-10
00193982586744CAPTIVATE3188.26193188.26192026-06-10
00193982586973CAPTIVATE3188.30113188.30112026-06-10
00193982586997CAPTIVATE3188.30133188.30132026-06-10
00193982587017CAPTIVATE3188.30153188.30152026-06-10
00193982587031CAPTIVATE3188.30173188.30172026-06-10
00193982587055CAPTIVATE3188.30193188.30192026-06-10
00193982587277CAPTIVATE3188.31143188.31142026-06-10
00193982587284CAPTIVATE3188.31153188.31152026-06-10
00193982587291CAPTIVATE3188.31163188.31162026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
08800322742945PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742952PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742969PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742976PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742983PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742990PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743003PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743010PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743027PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743034PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743041PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743058PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743065PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743072PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743089PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743096PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743102PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743119PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743126PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743133PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743140PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743157PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743171PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743188PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743195PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743201PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743218PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18