FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834707440
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
70-744
Catalog number
70-744
Device description
Curette, Columbia 4L-4R, Double-Ended, Size 6 Handle
Published
2018-04-18
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
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780207917PrimaryGS10
H834707440SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178020791710381780207917

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
00850083275648Intrace USAPILOTIS TECH LLCEMS2026-07-03
08404535019018Brasseler USAPeter Brasseler Holdings, LLCEMS2026-06-26
G149TBSB5050TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5060TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5070TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5080TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5100TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5120TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5130TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5140TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5160TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5170TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5180TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5200TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5210TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5220TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5230TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5240TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5250TBS BASICSACME ENTERPRISE.EMS2026-05-20
EZPF2423001G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423001GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423103G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105L0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423415G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13