FDA.reportPublic FDA data

PERMA-HAND

Primary DI
10705031006508
Brand
PERMA-HAND
Company
ETHICON, LLC
Model
591H
Catalog number
591H
Device description
Black Braided Silk, Nonabsorbable Surgical Suture
Published
2015-09-01
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

Contact Domains#

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
K946173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946173000STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKETHICON, Inc.1995-01-09GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031006502PackageGS136In Commercial Distribution
10705031006508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503100650230705031006502
1070503100650810705031006508

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031051805Coated VICRYLVCP260HVCP260H2015-09-01
10705031051874Coated VICRYLVCP267HVCP267H2015-09-01
10705031051911Coated VICRYLVCP269HVCP269H2015-09-01
10705031053038Coated VICRYLVCP417HVCP417H2015-09-01
10705031055933Coated VICRYLVCP870HVCP870H2015-09-01
10705031056213Coated VICRYLVCP958HVCP958H2015-09-01
10705031056237Coated VICRYLVCP959HVCP959H2015-09-01
10705031051744Coated VICRYLVCP232HVCP232H2015-09-01
10705031052475Coated VICRYLVCP339HVCP339H2015-09-01
10705031052499Coated VICRYLVCP340HVCP340H2015-09-01
10705031052635Coated VICRYLVCP352HVCP352H2015-09-01
10705031053823Coated VICRYLVCP497HVCP497H2015-09-01
10705031056114Coated VICRYLVCP944HVCP944H2015-09-01
10705031056121Coated VICRYLVCP945HVCP945H2015-09-01
10705031056145Coated VICRYLVCP946HVCP946H2015-09-01
10705031053519Coated VICRYLVCP468HVCP468H2015-09-01
10705031097889ETHIBOND EXCELEH7755HEH7755H2026-07-17
10705031102996ETHIBOND EXCELPE6680HPE6680H2026-07-17
10705031103085ETHIBOND EXCELPE7055HPE7055H2026-07-17
10705031238404ETHIBOND EXCELW975GW975G2026-07-17

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