FDA.reportPublic FDA data

Miltex® Padgett®

Primary DI
10381780038238
Brand
Miltex® Padgett®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
PM-670
Catalog number
PM-670
Device description
Integra® Miltex® ERICH ARCH BAR MATERIAL 1 METER ROLL
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYXLOCK, WIRE, AND LIGATURE, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYXLock, Wire, And Ligature, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061271000ERCH ARCH BAR, MODEL 38-690-00KLS-Martin L.P.2006-06-30DYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780038238PrimaryGS10
H834PM6700SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003823810381780038238

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Device Sizes#

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

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043178040Minne Ties Agile MMFInvisian Medical, LLCDYX2025-07-17
00385640085809MINNE TIESSummit Medical, Inc.DYX2025-03-06
00385640085816MINNE TIESSummit Medical, Inc.DYX2025-03-06
00850043178002Minne Ties Agile MMFInvisian Medical, LLCDYX2022-07-01
00850043178019Minne Ties Agile MMFInvisian Medical, LLCDYX2022-07-01
00850043178026Minne Ties Agile MMFInvisian Medical, LLCDYX2022-07-01
00860000906005MINNE TIES MT-1000KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00860000906012MINNE TIES MT-1001KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00860000906029MINNE TIES MT-1002KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00860000906036MINNE TIES MT-1003KEYSTONE MANUFACTURING, LLCDYX2021-08-17
00385640042383MINNE TIESSummit Medical, Inc.DYX2019-02-14
00385640042406MINNE TIESSummit Medical, Inc.DYX2019-02-14
00385640042420MINNE TIESSummit Medical, Inc.DYX2019-02-14
00385640041751MINNE TIESSummit Medical, Inc.DYX2019-01-09
00385640000642MINNE TIESSummit Medical, Inc.DYX2017-05-19
00385640028165MINNE TIESSummit Medical, Inc.DYX2017-05-19
00385640028172MINNE TIESSummit Medical, Inc.DYX2017-05-19
00385640028189MINNE TIESSummit Medical, Inc.DYX2017-05-19
10381780038221Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2016-12-29
M274P6700Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2016-12-29
00888118063090ARCH BARKLS-Martin L.P.DYX2016-09-20
H834PM6700Miltex® Padgett®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDYX2015-09-22