FDA.reportPublic FDA data

BEE PLIF

Primary DI
04251631415985
Brand
BEE PLIF
Company
NGMedical GmbH
Model
Shaver 7 x 24 mm
Catalog number
I329
Device description
All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques.
Published
2023-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211413000
K212050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211413000BEE PLIF CageNGMedical GmbH2021-08-27MAX
K212050000NGM WAVE PLIF CageNGMedical GmbH2021-12-01MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251631415985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251631415985042516314159854251631415985

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342615118
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251631415138BEE HACervical 4x14mm 4°SBHA414L4S2026-04-21
04251631415145BEE HACervical 4x14mm 8°SBHA414L8S2026-04-21
04251631415152BEE HACervical 4x14mm 12°SBHA414L12S2026-04-21
04251631415169BEE HACervical 5x14mm 4°SBHA514L4S2026-04-21
04251631415176BEE HACervical 5x14mm 8°SBHA514L8S2026-04-21
04251631415183BEE HACervical 5x14mm 12°SBHA514L12S2026-04-21
04251631415190BEE HACervical 6x14mm 4°SBHA614L4S2026-04-21
04251631415206BEE HACervical 6x14mm 8°SBHA614L8S2026-04-21
04251631415213BEE HACervical 6x14mm 12°SBHA614L12S2026-04-21
04251631415220BEE HACervical 7x14mm 4°SBHA714L4S2026-04-21
04251631415237BEE HACervical 7x14mm 8°SBHA714L8S2026-04-21
04251631415244BEE HACervical 7x14mm 12°SBHA714L12S2026-04-21
04251631415251BEE HACervical 8x14mm 4°SBHA814L4S2026-04-21
04251631415268BEE HACervical 8x14mm 8°SBHA814L8S2026-04-21
04251631415275BEE HACervical 8x14mm 12°SBHA814L12S2026-04-21
04251631415282BEE HACervical 9x14mm 4°SBHA914L4S2026-04-21
04251631415299BEE HACervical 9x14mm 8°SBHA914L8S2026-04-21
04251631415305BEE HACervical 9x14mm 12°SBHA914L12S2026-04-21
04251631415312BEE HACervical 10x14mm 4°SBHA1014L4S2026-04-21
04251631415329BEE HACervical 10x14mm 8°SBHA1014L8S2026-04-21

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