FDA.reportPublic FDA data

Integra®

Primary DI
10381780079859
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3714313
Catalog number
3714313
Device description
"Integra® Coakley Antrum Curette, 7"", Large, Acute Curve, #3"
Published
2018-09-17
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
KAPCURETTE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780079859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007985910381780079859

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus curetteA slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

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
Manufacturing date on label
true
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
09348811100368INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-28
09348811100382INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
09348811100979INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
00757770668410Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770684618Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770422944Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770424764Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770425716Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770431182Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434046Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434640Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770403004Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770406562Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770410859Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770411962Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770418589Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770419845Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770420506Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770422630Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770402779Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770403776Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770404483Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770406586Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770420360Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770423088Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00887482116203Symmetry PaparellaASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00887482119358Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00194613068608MSI Precision Specialty InstrumentsMed Saver, Inc.KAP2024-08-15
00840183527327BR Surgical, LLCBR Surgical, LLCKAP2024-07-16
00840183522537BR Surgical, LLCBR Surgical, LLCKAP2024-06-03