FDA.reportPublic FDA data

Tray for Montblanc Ankle Plate System

Primary DI
88000274099548
Brand
Tray for Montblanc Ankle Plate System
Company
MEDIFIELD MEDICAL Co., Ltd.
Model
MF001
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
88000274099548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8800027409954888000274099548

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
true
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

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Primary DI, Brand, Company table
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