FDA.reportPublic FDA data

Miltex®

Primary DI
10381780038450
Brand
Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
62508
Catalog number
62508
Device description
"18"" SZ3-0 SLK BLK NON-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
GAPSUTURE, NONABSORBABLE, SILK

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020901000SERRALSILKSerral, S.A. DE C.V.2002-04-26GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780038450PrimaryGS10
H834625081SecondaryHIBCC0
00381780038453Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178003845010381780038450
00381780038453003817800384533817800384530381780038453

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."

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
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11
10381780154501Integra® Ruggles®-Redmond™R2382R23822016-08-11
10381780154518Integra® Ruggles®-Redmond™R2384R23842016-08-11
10381780154525Integra® Ruggles®-Redmond™R2389R23892016-08-11
10381780154532Integra® Ruggles®-Redmond™R2396R23962016-08-11
10381780154549Integra® Ruggles®-Redmond™R2397R23972016-08-11
10381780154556Integra® Ruggles®-Redmond™R2398R23982016-08-11
10381780154563Integra® Ruggles®-Redmond™R2399R23992016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00381780363883Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGAP2017-01-05
04038653826230SilkamB BRAUN SURGICAL SAGAP2015-11-12
04038653826469SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653826513SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653741502SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741526SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741601SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741700SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741786SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741816SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741830SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741854SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741892SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741915SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742196SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742257SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742271SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742776SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742936SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742950SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742974SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742998SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741243SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741281SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741403SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741441SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741625SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743131SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743438SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743414SilkamB BRAUN SURGICAL SAGAP2015-08-20