METICULY Patient-specific titanium maxillofacial mesh implant

Primary DI
08859751212123
Brand
METICULY Patient-specific titanium maxillofacial mesh implant
Company
METICULY COMPANY LIMITED
Model
MF-212
Device description
METICULY Patient-specific titanium maxillofacial mesh implant : Orbital Mesh S non-sterile
Published
2024-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232889000METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd.2024-04-30JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859751212120PackageGS11In Commercial Distribution
08859751212123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885975121212018859751212120
08859751212123088597512121238859751212123

GMDN Terms#

Term, Definition table
TermDefinition
Orbital wall/rim prosthesisAn implantable ocular device used to reconstruct the orbital roof, floor, medial and/or lateral walls, and/or rim of the eye socket. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment and is intended to be used in conjunction with an artificial eye (not included).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
661695214
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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