FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834262551
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
26-255
Device description
SMITH-Petersen Laminectomy Rongeur, straight jaws
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
10381780126966PrimaryGS10
H834262551SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012696610381780126966

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical rongeurA hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. 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
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
10381780127901Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127918Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127925Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127956Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780127963Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128182Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128199Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128205Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780136408Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780142928Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780126744Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126751Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126768Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126775Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126782Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126836Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126874Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126904Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126911Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127048Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127055Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127062Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127079Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127086Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127093Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127109Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127116Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127123Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127130Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127147Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11