FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780394976
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
THM29X-KG
Catalog number
THM29X-KG
Device description
Margin Trimmer, 29, GTX, Black-Green, Tactile Tone™
Published
2018-04-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJZKnife, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780394976PrimaryGS10
H834THM29XKG0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178039497610381780394976

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889950148003Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2026-02-24
10889950148010Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2026-02-24
07898506852307QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506854684QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506854929QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506854936QuinelatoSchobell Industrial LtdaEJZ2023-01-10
07898506843664QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843671QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843701QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843718QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843732QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506843954QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506847433QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506852291QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506852314QuinelatoSchobell Industrial LtdaEJZ2022-12-08
07898506852321QuinelatoSchobell Industrial LtdaEJZ2022-12-08
10889950006433HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006440HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006457HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006464HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006471HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006488HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006495HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006501HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006518HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006525HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006532HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006549HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006556HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12
10889950006570HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2020-11-12