FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834621050
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
62-105
Catalog number
62-105
Device description
Osteotome 5-7/8", Blunt, 4mm Wide
Published
2018-02-26
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780449515PrimaryGS10
H834621050SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178044951510381780449515

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. 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
true
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
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408574Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408581Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408727Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408734Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408741Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408758Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408765Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408772Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780188087Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188094Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188100Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188117Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188124Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188131Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188148Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188155Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188162Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188179Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188186Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188193Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188209Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188216Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188223Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188230Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188346Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02