FDA.reportPublic FDA data

Sterile PTFE Surgical Suture

Primary DI
08056646509249
Brand
Sterile PTFE Surgical Suture
Company
OMNIA SRL
Model
PSNPTFE2
Device description
PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 16MM 3/8 CIRCLE REVERSE CUTTING
Published
2021-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBYSuture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056646500864PrimaryGS10
08056646509256PrimaryGS10
08056646509249Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056646500864080566465008648056646500864
08056646509256080566465092568056646509256
08056646509249080566465092498056646509249

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT AND KEEP DRY

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390524527453info@omniaspa.eu

Regulatory Flags#

DUNS number
447696675
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052141311806Irrigation Line32.F0139.002026-03-27
08052141312025Irrigation Line32.F0170.002026-03-27
08052141312780Irrigation Line32.F0006.002026-03-27
08052141312865Irrigation Line32.F0134.002026-03-27
08052141312940Irrigation Line32.F0161.002026-03-27
08052141313602Irrigation Line32.F0105.002026-03-27
08056646500291Basic Implant Set12.S5621.002026-03-27
08056646500307Implantology Set12.S4671.002026-03-27
08056646500321Oral Surgery Set12.S4096.002026-03-27
08056646500482Oral Surgery Pack12.S8318.00 2026-03-27
08056646508846Adhesive Films32.U0020.002026-03-27
08056646508945Adhesive Films32.U4020.002026-03-27
08056646503018Sterile PTFE Surgical Suture32.Z4400.002017-02-27
08056646500017Sterile PTFE Surgical Suture32.Z3130.002016-05-31
08056646500031Sterile PTFE Surgical Suture32.Z3141.002016-07-07
08056646500055Sterile PTFE Surgical Suture32.Z3150.002016-08-29
08056646500079Sterile PTFE Surgical Suture32.Z3160.002016-08-29
08056646500086Sterile PTFE Surgical Suture32.Z3151.002016-08-29
08056646500116Sterile PTFE Surgical Suture32.Z3260.002016-08-29
08056646500123Sterile PTFE Surgical Suture32.Z3240.002016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500857Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500864Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500871Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500888Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500895Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500901Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500918Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500925Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500932Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500949Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500956Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646500963Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509232Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509256Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509270Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509294Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509317Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509331Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509355Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509379Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509393Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509416Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509430Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
08056646509454Sterile PTFE Surgical SutureOMNIA SRLNBY2021-02-07
10652927322986Demetech PTFEDemetech CorporationNBY2019-07-11
10652927432357Demetech PTFEDemetech CorporationNBY2019-07-11
10652927432364Demetech PTFEDemetech CorporationNBY2019-07-11
10652927668039Demetech PTFEDemetech CorporationNBY2019-07-10
10652927670148Demetech PTFEDemetech CorporationNBY2019-07-10
10652927670179Demetech PTFEDemetech CorporationNBY2019-07-10