FDA.reportPublic FDA data

DILATOR

Primary DI
00888118054579
Brand
DILATOR
Company
KLS-Martin L.P.
Model
27-113-14-07
Device description
TRACHEAL, LABORDE
Published
2018-09-26
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
00888118054579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118054579008881180545798881180545790888118054579

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462917778evonosevonos GmbH & Co. KGKCG2026-08-14
04054462917785evonosevonos GmbH & Co. KGKCG2026-08-14
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