FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H8343013850
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
30-1385
Catalog number
30-1385
Device description
Heaney Uterine Biopsy Curette 9-3/4", Serrated Loop
Published
2018-01-29
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
HCYCURETTE, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780428022PrimaryGS10
H8343013850SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042802210381780428022

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. 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
00190776395636MillenniumAvalign Technologies, Inc.HCY2026-07-14
10198956388789CARDINAL HEALTHCardinal Health 200, LLCHCY2026-07-06
00850083275464Intrace USAPILOTIS TECH LLCHCY2026-07-03
00850083275488Intrace USAPILOTIS TECH LLCHCY2026-07-03
00198506091537ELMED INCORPORATEDELMED INCORPORATEDHCY2026-06-10
00198506091544ELMED INCORPORATEDELMED INCORPORATEDHCY2026-06-10
10198956475366CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-05
10198956366428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
10198956476530CARDINAL HEALTHCardinal Health 200, LLCHCY2026-06-01
07898506815111QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815135QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815159QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815319QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815333QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815340QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815357QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506815364QuinelatoSchobell Industrial LtdaHCY2023-01-09
07898506840922QuinelatoSchobell Industrial LtdaHCY2023-01-09
10195594745776CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-18
10195594684549CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-14
10195594685485CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-08
10195594735142CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-07
10195594727260CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594727314CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594740702CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-06
10195594623807CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-24
10195594715830CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594717186CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594727680CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23
10195594730994CARDINAL HEALTHCardinal Health 200, LLCHCY2022-06-23