FDA.reportPublic FDA data

MedSource Tracheostomy Hook

Primary DI
00840155400535
Brand
MedSource Tracheostomy Hook
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-29100
Catalog number
Not Applicable
Device description
MedSource Tracheostomy Hook
Published
2021-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840155400535PackageGS1200In Commercial Distribution
00840155408852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155400535008401554005358401554005350840155400535
00840155408852008401554088528401554088520840155408852

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal surgery dilator, single-useA sterile, 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 may be in the form of a slender hollow or solid cylinder or a scissors-like instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041674552
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816703025475MedSource Emesis BagMS-17360-RCSNot Applicable2021-05-10
00816703026526MedSource Airway DevicesMS-23908-RCSNot Applicable2021-05-18
00816703027172MedSource Traction SplintMS-TLS-3-RCSNot Applicable2021-08-16
00816703020838MedSource PRN, Male Luer PrositeMS-830112016-06-30
00816703021118MedSource NP Needle Free ConnectorMS-899792016-06-30
00840155421042Nasopharyngeal Airway1011-450002025-07-15
00840155401419MedSource CathetersMS-87414Not Applicable2023-01-09
00840155406179MedSource CathetersMS-87416Not Applicable2023-01-09
00840155413870MedSource CathetersMS-87420Not Applicable2023-01-09
00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
00840155413931MedSource CathetersMS-87424Not Applicable2023-01-09
00840155413962MedSource CathetersMS-874202Not Applicable2023-01-09
00840155413993MedSource Winged CathetersMS-84214WNot Applicable2023-01-30
00840155414020MedSource Winged CathetersMS-84216WNot Applicable2023-01-30
00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
00816703023129Elite CPR Face ShieldELITE-21105Not Applicable2021-04-20
00816703023143Elite CPR Face ShieldELITE-21106Not Applicable2021-04-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06438394002685Activa InstrumentBioretec OyMDM2026-03-23
06438394002692Activa InstrumentBioretec OyMDM2026-03-23
06438394020382Activa InstrumentBioretec OyMDM2026-03-23
06438394010956Activa InstrumentBioretec OyMDM2026-03-23
00198506089619ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-17
00888867519459Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519473Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519503Arthrex®ARTHREX, INC.MDM2026-03-16
00888867519510Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529755Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529793Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529823Arthrex®ARTHREX, INC.MDM2026-03-16
00198506089510ELMED INCORPORATEDELMED INCORPORATEDMDM2026-03-13
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00810158219243PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
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00810158219359PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219373PRINCETONPrinceton Medical Group, Inc.MDM2026-03-12
00810158219007PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219014PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219021PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219038PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219069PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11
00810158219090PRINCETONPrinceton Medical Group, Inc.MDM2026-03-11