FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780362722
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
18-1950-7
Catalog number
18-1950-7
Device description
"Integra® Miltex® Arruga Lacrimal Trephine, 2-1/8"", 7mm diameter, without center point"
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRHTrephine, manual, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780362722PrimaryGS10
H83418195071SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036272210381780362722

GMDN Terms#

Term, Definition table
TermDefinition
Corneal trephine, reusableAn ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylinder, of different diameters, having a circular, saw-like working edge. It is an exchangeable device that may be attached to a manually rotated handle or to a powered rotary surgical handpiece. This device is typically 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
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02
10381780519195CODMAN® HAKIM®82311682-31162020-06-02
10381780519249CODMAN® HAKIM®82316482-31642020-06-02
10381780519256CODMAN® HAKIM®82318282-31822020-06-02
10381780519263CODMAN® HAKIM®82318482-31842020-06-02
10381780519447CODMAN® HAKIM®82328182-32812020-06-02
10381780519478CODMAN® HAKIM®82328482-32842020-06-02
10381780519485CODMAN® HAKIM®82328582-32852020-06-02
10381780519751CODMAN® HAKIM®82382182-38212020-06-02
10381780519768CODMAN® HAKIM®82382282-38222020-06-02
10381780519799CODMAN® HAKIM®82382582-38252020-06-02
10381780519805CODMAN® HAKIM®82383282-38322020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668146460BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146484BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146491BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146507BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146514BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146521BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146538BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146545BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146552BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146569BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146576BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146590BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146606BarronKATENA PRODUCTS, INC.HRH2026-06-10
05055445956165SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956172SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956189SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956196SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956202SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956219SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956226SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956233SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956240SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956257SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956264SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956271SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956288SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956295SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956301SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956318SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956325SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12