FDA.reportPublic FDA data

Integra®

Primary DI
10381780086505
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3734168
Catalog number
3734168
Device description
Integra® Laborde Tracheal Dilator, 3 Blades, Two Flat, One Cup
Published
2018-10-24
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
KCGDILATOR, TRACHEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCGDilator, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780086505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008650510381780086505

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal surgery dilator, reusableA hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. 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
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
00190776399351MillenniumAvalign Technologies, Inc.KCG2025-05-30
04049047041818GimmiGimmi GmbHKCG2025-05-08
04049047700043GimmiGimmi GmbHKCG2025-05-08
G043280420BEARBear-Ent, LLCKCG2024-08-03
00840183513764BR Surgical, LLCBR Surgical, LLCKCG2024-06-10
00888515246850BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
00888515246867BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
00888515246881BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCG2024-02-28
G586E98477130Novo SurgicalNOVO SURGICAL, INC.KCG2023-12-18
G25010005140Laborde Dilator ForcepN S SURGICAL COMPANYKCG2023-04-29
00842331179754Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-14
00842331160448Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-13
00842331139123Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-11
00842331136054Novo Surgical Inc. NOVO SURGICAL, INC.KCG2022-11-10
00887482049303Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482049310Symmetry LabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482124123Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482124130Symmetry LabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-10-13
00887482002322Symmetry DelabordeASPEN SURGICAL PRODUCTS, INC.KCG2022-09-07
00887482002605Symmetry TrousseauASPEN SURGICAL PRODUCTS, INC.KCG2022-09-07
00190776184469MillenniumAvalign Technologies, Inc.KCG2021-11-01
00190776184476MillenniumAvalign Technologies, Inc.KCG2021-11-01
04035324017263TRACOE experc Dilation SetTracoe medical GmbHKCG2021-03-05
04046826135782MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
04046826135799MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
04046826135805MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKCG2020-09-24
10649111117039SklarSKLAR CORPORATIONKCG2019-03-13
10649111134012SklarSKLAR CORPORATIONKCG2019-03-13
10649111397165SklarSKLAR CORPORATIONKCG2019-03-13
10649111397172SklarSKLAR CORPORATIONKCG2019-03-13