FDA.reportPublic FDA data

HAVEL'S

Primary DI
B070B68E0
Brand
HAVEL'S
Company
Havel's Incorporated
Model
"C7 3/0 BBS 18""/45 CM ON CARD"
Catalog number
B68E
Published
2016-06-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B070B68E1PackageHIBCC12In Commercial Distribution
B070B68E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture"A 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 device(s) [e.g., needle, passer] intended to facilitate suture application. 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."

Regulatory Flags#

DUNS number
101497568
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
B070A64E0HAVEL'S"SUT 3-0 PLAIN GUT 18""/HS-24"A64E2016-06-16
B070A66CH0HAVEL'S"SUT 4-0 CHROMIC GUT 27""/DS-18"A66CH2016-06-16
B070A66CR0HAVEL'S"CHROMIC GUT 3/0 27"" C6 *SUB*"A66CR2016-06-16
B070A66DL0HAVEL'S"SUT 4-0 PLAIN GUT 18""/DS-18"A66DL2016-06-16
B070A66EL0HAVEL'S"3/0 PLAIN GUT 18"" DS-18"A66EL2016-06-16
B070A68EL0HAVEL'S"SUT. 3-0 PLAIN GUT 18""/DS-24"2016-06-16
B070A77C0HAVEL'S "SUT 5-0 PLAIN GUT 18""/DS-12"A77C2016-06-16
B070A77CH0HAVEL'S"SUT. 4-0 CHROMIC GUT 18""/DS-12"A77CH2016-06-16
B070B64E0HAVEL'S"SUT. 3-0 SILK 18""/HS-24"B64E2016-06-16
B070B65CN0HAVEL'S"SUT. 5-0 SILK BLK BR 18""/HS-16"B65CN2016-06-16
B070B66D0HAVEL'S"SUT 4-0 SILK BLK 18""/DS-18"B66D2016-06-16
B070B66E0HAVEL'S"SUT. 3-0 SILK BLK 18""/DS-18"B66E2016-06-16
B070B66K0HAVEL'S"SUT. 5-0 SILK BLK 18""/DS-18"B66K2016-06-16
B070B77C0HAVEL'S"SUT 5-0 SILK BLK 18""/DS-12"B77C2016-06-16
B070B77D0HAVEL'S"SUT. 4-0 SILK BLK 18""/DS-12"B77D2016-06-16
B070BN61B0HAVEL'S"SUT 6-0 NYLON 18""/DSS-10"BN61B2016-06-16
B070BN62B0HAVEL'S "SUT 6-0 NYLON 18""/DSS-12"BN62B2016-06-16
B070BN62C0HAVEL'S"SUT.5-0 BK NYLON 18""/DSM-13"BN62C2016-06-16
B070BN62D0HAVEL'S"SUT 4-0 NYLON 18""/DSS-12"BN62D2016-06-16
B070BN65B0HAVEL'S"6/0 BLK MONO NYLON 18"" DS-16"BN65B2016-06-16

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