FDA.reportPublic FDA data

Montblanc Lag Drill Bit

Primary DI
08809958987287
Brand
Montblanc Lag Drill Bit
Company
MEDIFIELD MEDICAL Co., Ltd.
Model
RFM021
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

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
08809958987287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809958987287088099589872878809958987287

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

Contacts#

Phone, Email table
PhoneEmail
+821089806787medifield329@gmail.com

Regulatory Flags#

DUNS number
695956893
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800274091061Montblanc Depth GaugeRFM0592026-06-22
08800274099555Tray for Montblanc Radius Plate SystemMF0022026-06-22
08809958987065Montblanc Depth GaugeRFM0102026-06-22
08809958987072Montblanc Driver ShaftRFM0042026-06-22
08809958987089Montblanc Driver ShaftRFM0232026-06-22
08809958987096Montblanc Plate TackRFM0072026-06-22
08809958987126Montblanc Cortical Drill GuideRFM0022026-06-22
08809958987133Montblanc Cortical Drill GuideRFM0172026-06-22
08809958987140Montblanc Lag Drill GuideRFM0182026-06-22
08809958987157Montblanc Locking Drill SleeveRFM0062026-06-22
08809958987164Montblanc Locking Drill SleeveRFM0192026-06-22
08809958987171Montblanc Guide Block Drill GuideRFM0052026-06-22
08809958987188Montblanc Guide Block - NarrowRFM0112026-06-22
08809958987195Montblanc Guide Block - NarrowRFM0122026-06-22
08809958987201Montblanc Guide Block - StandardRFM0132026-06-22
08809958987218Montblanc Guide Block - StandardRFM0142026-06-22
08809958987225Montblanc Guide Block - WideRFM0152026-06-22
08809958987232Montblanc Guide Block - WideRFM0162026-06-22
08809958987256Montblanc AO Type HandleRFM0012026-06-22
08809958987263Montblanc Drill BitRFM0032026-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525324Onyx 6.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525348Onyx 4.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525355Onyx 5.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525362Onyx 6.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525379Onyx 7.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
00810055525393Onyx Straight ProbeSi-Bone Inc.LXH2026-09-29
00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29
00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
00810055525461Onyx Counter TorqueSi-Bone Inc.LXH2026-09-29
00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29