FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780506348
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
20-426
Catalog number
20-426
Device description
"Integra® Miltex® Tonsil Needle, With Luer Lock, 4-1/4"", 0.65mm Diameter, Straight"
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBRNEEDLE, TONSIL SUTURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780506348PrimaryGS10
H834204260SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050634810381780506348

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter65Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00194613112448MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613115449MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613109752MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-03-21
00190776388744MillenniumAvalign Technologies, Inc.KBR2024-11-14
00887482173800Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-15
00887482046562Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119167Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119174Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123966Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123973Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00840343722203GEN2SURGIX MEDICAL LLCKBR2024-04-23
G586E8306200Novo SurgicalNOVO SURGICAL, INC.KBR2023-12-18
00840343720414GEN2SURGIX MEDICAL LLCKBR2023-12-08
00190776303990MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776304904MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776044077AvalignAvalign Technologies, Inc.KBR2023-09-28
00190776290733MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319625MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319700MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319885MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322281MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322298MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776373801MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776378264MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00840343716240GEN2SURGIX MEDICAL LLCKBR2023-03-22
00840343715427GEN2SURGIX MEDICAL LLCKBR2022-12-29
14026704804815PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
14026704805010PILLINGTELEFLEX INCORPORATEDKBR2022-12-08