FDA.reportPublic FDA data

MANI Sutures Silk

Primary DI
04546951401931
Brand
MANI Sutures Silk
Company
MANI, INC.
Model
2023S
Catalog number
2023S
Device description
MANI Ophthalmic Sutures
Published
2016-06-04
Public version status
Update
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
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053638000MANI NEEDLE & SUTURE PACK (SILK)Mani, Inc.2006-05-19GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14546951401938PackageGS112In Commercial Distribution
04546951401931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454695140193814546951401938
04546951401931045469514019314546951401931

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture, sterileA sterile, 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 needle. 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.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690622428
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08
04546951601447MANI CARBIDE BURS1/4 (CA)2026-04-08
04546951601454MANI CARBIDE BURS1/2 (CA)2026-04-08
04546951601461MANI CARBIDE BURS1 (CA)2026-04-08
04546951601478MANI CARBIDE BURS2 (CA)2026-04-08
04546951601485MANI CARBIDE BURS3 (CA)2026-04-08
04546951601492MANI CARBIDE BURS4 (CA)2026-04-08
04546951601508MANI CARBIDE BURS5 (CA)2026-04-08
04546951601515MANI CARBIDE BURS7 (CA)2026-04-08
04546951601522MANI CARBIDE BURS8 (CA)2026-04-08
04546951400729MANI Sutures Polyester337833782016-06-04
04546951400750MANI Sutures Polyester337533752016-06-04
04546951400767MANI Sutures Polyester337433742016-06-04
04546951400859MANI Sutures Polyester337333732016-06-04
04546951401429MANI Sutures Polyester141214122016-06-04
04546951402662MANI Sutures Polyester337133712016-06-04
04546951402679MANI Sutures Polyester337033702016-06-04
04546951400538MANI Sutures Polyester435743572016-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028222SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06