FDA.report

Onatec

Primary DI
10848782006240
Brand
Onatec
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
OF311830
Catalog number
OF311830
Device description
Onafil, 1 arm(s) HDK-18-530 P 4/0, 45 cm Silk black
Published
2022-04-27
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

Related Records

Contact Domains

Product Codes

CodeName
GAPSuture, Nonabsorbable, Silk

Product Code Classifications

CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848782006240PackageGS112In Commercial Distribution
00848782006243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878200624010848782006240
00848782006243008487820062438487820062430848782006243

GMDN Terms

TermDefinition
Silk sutureA natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags

DUNS number
812762226
Device count
1
DM exempt
true
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 DIBrandModelCatalogPublished
10848782051516QuillVLP-4160 2025-07-11
00848782051786OnatecOL144091OL1440912025-06-02
00848782051793OnatecOL415691OL4156912025-06-02
00848782051809OnatecOL456291OL4562912025-06-02
10848782051813OnatecON456291ON4562912025-06-02
10848782051820OnatecON245071ON2450712025-06-02
10848782051837OnatecON146571ON1465712025-06-02
10848782051844OnatecON244081ON2440812025-06-02
10848782051851OnatecON454081ON4540812025-06-02
00848782051861OnatecOL145091OL1450912025-06-02
00848782051878OnatecOL415591OL4155912025-06-02
00848782051892OnatecOL145081OL1450812025-06-02
00848782051908OnatecOL415681OL4156812025-06-02
10848782051912OnatecOE261391OE2613912025-06-02
10848782051929OnatecOE471691OE4716912025-06-02
10848782051936OnatecON456671ON4566712025-06-02
10848782051943OnatecOE481691OE4816912025-06-02
10848782051950OnatecOE341331OE3413312025-06-02
00848782051960OnatecOL494891OL4948912025-06-02
00848782051977OnatecOL415592OL4155922025-06-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08903837747518SILKHEALTHIUM MEDTECH LIMITEDGAP2026-05-25
10841336117645Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117898Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
00841336117907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117911Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117928Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117935Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117942Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
10841336117959Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGAP2025-09-28
00840277410153SilkRIVERPOINT MEDICAL, LLCGAP2025-07-29
10814639026747Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026754Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026761Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026778Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026785Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10814639026792Premium UNIFY Silk SuturesAPPLIED DENTAL, INC.GAP2025-06-20
10840277408577SilkRIVERPOINT MEDICAL, LLCGAP2025-06-18
10840277408591RiversilkRIVERPOINT MEDICAL, LLCGAP2025-06-18
10848782052025OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052032OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052049OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052056OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052063OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052070OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10848782052278OnatecSurgical Specialties México, S. de R.L. de C.V.GAP2025-06-02
10840277409192SilkRIVERPOINT MEDICAL, LLCGAP2025-03-13
10840277409208SilkRIVERPOINT MEDICAL, LLCGAP2025-03-13
10840277408560SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408584RiversilkRIVERPOINT MEDICAL, LLCGAP2025-02-28
10840277408843SilkRIVERPOINT MEDICAL, LLCGAP2025-02-28