BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Duatene

DI: 10884521726604 · Model: DTN10RX3 · SOFRADIM PRODUCTION

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: Duatene
Primary DI: 10884521726604
Version / Model: DTN10RX3
Catalog Number: DTN10RX3
Company Name: SOFRADIM PRODUCTION
Labeler DUNS: 576342646
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-03-12
Public Version: 5
Public Version Date: 2022-06-10
Public Version Status: Update
Public Device Record Key: 7d8b81b7-c93d-47e5-ad4f-4e6275f3cf6c

Device Description

Bilayer Mesh Monofilament Polypropylene

Device Characteristics

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

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTL	Mesh, surgical, polymeric	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60300	Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable	An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521726601	GS1	CASE	3	In Commercial Distribution
Primary	10884521726604	GS1

Customer Contacts

Phone: +1(508)261-8000
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172395	000

Device Sizes

Type	Value	Unit	Text
Width	13	Centimeter
Height	6	Centimeter
Outer Diameter	10	Centimeter
Device Size Text, specify			No;

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: No;