BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Silicone Carving Implant

DI: B4906006059 · Model: D · Aart

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Silicone Carving Implant
Primary DI: B4906006059
Version / Model: D
Catalog Number: 600-605-9
Company Name: Aart
Labeler DUNS: 091356894
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-09-02
Public Version: 2
Public Version Date: 2026-04-22
Public Version Status: Update
Public Device Record Key: 58b35d05-f8b6-4087-83f7-06e50d98d4eb
Distribution End Date: 2025-09-08

Device Description

Silicone Carving Implant Style 6 Size 5 with Suture Tabs

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: Yes
Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIB	Elastomer, Silicone Block	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45230	Silicone-block tissue reconstructive material	A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B4906006059	HIBCC

Customer Contacts

Phone: (775) 853-6800
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021820	000