FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336117969
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
L-8661B
Catalog number
L-8661B
Device description
Individual Salvin 5-0 Polypropylene BlueMonoC6(FS-
Published
2025-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAWSuture, nonabsorbable, synthetic, polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001185000POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USPCp Medical2000-06-23GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841336117966PackageGS112In Commercial Distribution
00841336117969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084133611796610841336117966
00841336117969008413361179698413361179690841336117969

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., 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.

Regulatory Flags#

DUNS number
113344790
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841336111905Allo-3D-PlusALLO-3D-PLUS-1.0ALLO-3D-PLUS-1.02024-07-11
00841336111912Allo-3D-PlusALLO-3D-PLUS-2.0ALLO-3D-PLUS-2.02024-07-11
00841336138766Salvin Dental SpecialtiesOFIBER-0.5CCOFIBER-0.5CC2025-09-28
00841336138773Salvin Dental SpecialtiesOFIBER-1.0CCOFIBER-1.0CC2025-09-28
00841336138797Salvin Dental SpecialtiesOFIBER-PLUS-0.5CCOFIBER-PLUS-0.5CC2025-09-28
00841336138803Salvin Dental SpecialtiesOFIBER-PLUS-1.0CCOFIBER-PLUS-1.0CC2025-09-28
00841336114395Salvin Dental SpecialtiesDEMIN-CORT-L-5.0DEMIN-CORT-L-5.02024-12-11
00841336125704Salvin Dental SpecialtiesSALVINOSS-0.5SALVINOSS-0.52024-12-11
00841336125711Salvin Dental SpecialtiesSALVINOSS-1.0SALVINOSS-1.02024-12-11
00841336125728Salvin Dental SpecialtiesSALVINOSS-2.5SALVINOSS-2.52024-12-11
00841336125735Salvin Dental SpecialtiesSALVINOSS-COLL-100MGSALVINOSS-COLL-100MG2024-12-11
00841336125759Salvin Dental SpecialtiesSALVINOSS-COLL-250MGSALVINOSS-COLL-250MG2024-12-11
00841336136229Salvin Dental SpecialtiesMIN-CAN-2.00MIN-CAN-2.002024-12-11
00841336138780Salvin Dental SpecialtiesOFIBER-2.5CCOFIBER-2.5CC2024-12-11
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27

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