FDA.reportPublic FDA data

HAVEL'S

Primary DI
B070A68EL0
Brand
HAVEL'S
Company
Havel's Incorporated
Model
"SUT. 3-0 PLAIN GUT 18""/DS-24"
Device description
SUTURE 3-0 PLAIN GUT 18'/DS-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B070A68EL1PackageHIBCC12In Commercial Distribution
B070A68EL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-638-4770RHUNLEY@HAVELS.COM

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
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
B070B68E0HAVEL'S"C7 3/0 BBS 18""/45 CM ON CARD"B68E2016-06-16
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
00848782052455SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-08-26
00840118621410Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621427Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621434Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00840118621441Endure IndustriesENDURE INDUSTRIESGAL2026-08-14
00814639026962Premium UNIFY Fast Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026979Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639026993Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027020Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00814639027051Premium UNIFY Chromic SuturesAPPLIED DENTAL, INC.GAL2026-08-07
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06