FDA.reportPublic FDA data

T14 4-0 Vio Br Pga 27"/70cm

Primary DI
10848782008701
Brand
T14 4-0 Vio Br Pga 27"/70cm
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
310BC
Catalog number
310
Device description
T14 4-0 Vio Br Pga 27"/70cm
Published
2015-10-20
Public version status
Update
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
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782008701PackageGS112In Commercial Distribution
00848782008704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878200870110848782008701
00848782008704008487820087048487820087040848782008704

GMDN Terms#

Term, Definition table
TermDefinition
Polyglycolic acid sutureA sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837747457Polyglactin 910HEALTHIUM MEDTECH LIMITEDGAM2026-05-25
00810126508331Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508348Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
10817169023019Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00817169023005Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-17
00810126508232Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508249Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508256Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
00810126508263Basik by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGAM2026-03-11
03661522100189OPTIME®PETERS SURGICALGAM2026-03-09
03661522100196OPTIME®PETERS SURGICALGAM2026-03-09
03661522100219OPTIME®PETERS SURGICALGAM2026-03-09
03661522100714OPTIME®PETERS SURGICALGAM2026-03-09
03661522100721OPTIME®PETERS SURGICALGAM2026-03-09
03661522100738OPTIME®PETERS SURGICALGAM2026-03-09
03661522100752OPTIME®PETERS SURGICALGAM2026-03-09
03661522100868OPTIME®PETERS SURGICALGAM2026-03-09
03661522100875OPTIME®PETERS SURGICALGAM2026-03-09
03661522101414OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101421OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101438OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101445OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101452OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101469OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101476OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101483OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101490OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101506OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101513OPTIME R®PETERS SURGICALGAM2026-03-09
03661522101575OPTIME®PETERS SURGICALGAM2026-03-09