FDA.reportPublic FDA data

Sharpoint Plus 8-0 V BRD PGA 8"/20CM 2xHLZ

Primary DI
10848782034014
Brand
Sharpoint Plus 8-0 V BRD PGA 8"/20CM 2xHLZ
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
G574N
Catalog number
G574N
Device description
8-0 V BRD PGA 8"/20CM 2xHLZ
Published
2021-03-24
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
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
10848782034014PackageGS112In Commercial Distribution
00848782034017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878203401410848782034014
00848782034017008487820340178487820340170848782034017

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. 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