FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780152361
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
26-30
Catalog number
26-30
Device description
HUDSON Brace Set, Standard Thumbscrew Chuck
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780152361PrimaryGS10
H83426300SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178015236110381780152361

GMDN Terms#

Term, Definition table
TermDefinition
Trephining power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to function as a craniotome when an appropriate cutter is inserted. It is inserted through a pre-drilled bur hole or perforator hole and is used to cut a flap in the bone of the skull vault (calvarium). It includes a small shielding tip at the distal end to prevent the end of the cutter penetrating the dura mater membrane. This is a reusable device.

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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B775635CK0PHASORPHASOR HEALTH LLCHBG2026-01-19
30381780544382Integra®INTEGRA PAIN MANAGEMENTHBG2025-08-20
30381780544399Integra®INTEGRA PAIN MANAGEMENTHBG2025-08-20
10381780537304Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780263890Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537328Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537335Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537342Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
G2843520100Drill BitNeurovention LLCHBG2024-10-17
00887482000892Symmetry Surgical®SYMMETRY SURGICAL INC.HBG2024-08-07
00842962140079HNM MEDICALHNM STAINLESS, LLC.HBG2023-04-02
00842962140086HNM MEDICALHNM STAINLESS, LLC.HBG2023-04-02
G28435201Drill BitNeurovention LLCHBG2022-06-21
00850359007959SmartTipCLEARPOINT NEURO, INC.HBG2021-04-07
10381780386964Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2021-03-02
00850359007348SmartTwistCLEARPOINT NEURO, INC.HBG2021-01-22
00850359007355SmartTipCLEARPOINT NEURO, INC.HBG2021-01-22
00850359007362SmartTipCLEARPOINT NEURO, INC.HBG2021-01-22
10381780514749CODMAN® GHAJAR GUIDEINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-04-01
10381780514701CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-02-28
10381780514718CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-02-28
M711LS4250Neuro & Craniofacial Fixation SystemINNO Holdings, Inc.HBG2018-08-13
M274290LBL1901Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274290SBL1901Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21241Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21251Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21281Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21291Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21301Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21311Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29