FDA.reportPublic FDA data

Miltex®

Primary DI
10381780038368
Brand
Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
62502
Catalog number
62502
Device description
"18"" SZ 3-0 CHRMIC GUT ABS C-6 NEEDLE CIR REV CUT"
Published
2015-09-22
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020597000SERRALGUTSerral, S.A. DE C.V.2002-08-14GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780038368PrimaryGS10
H834625021SecondaryHIBCC0
00381780038361Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178003836810381780038368
00381780038361003817800383613817800383610381780038361

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, 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.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00848782052790SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052806SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052813SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052820SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052837SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052844SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052851SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052875SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052882SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052899SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052905SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052912SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052929SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052936SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06