FDA.reportPublic FDA data

Medical Action Industries

Primary DI
10809160023655
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
56449
Published
2016-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCHHOOK, TRACHEAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160023652PackageGS150Not in Commercial Distribution
10809160023655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916002365220809160023652
1080916002365510809160023655

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160226100Splash Medical Devices715622019-02-05
10809160522790Medical Action Industries851072026-06-05
10809160522806Medical Action Industries851642026-06-05
10809160522479Medical Action Industries848692026-06-03
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10
10809160520635Medical Action Industries83349B2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613031459MSI Precision Specialty InstrumentsMed Saver, Inc.KCH2025-08-01
04049047041801GimmiGimmi GmbHKCH2025-05-08
04049047014348GimmiGimmi GmbHKCH2025-04-24
04049047038078GimmiGimmi GmbHKCH2025-04-24
00887482058640Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KCH2024-08-07
00840183513825BR Surgical, LLCBR Surgical, LLCKCH2024-06-10
00190776390204MillenniumAvalign Technologies, Inc.KCH2024-05-31
00190776388997MillenniumAvalign Technologies, Inc.KCH2024-05-16
G043280300BEARBear-Ent, LLCKCH2024-04-25
00888515035676BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035690BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035706BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035720BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035737BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035744BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035751BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
G586G93151250Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
G586G93151260Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
00190776045661AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045678AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045777AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223892AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223939AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776321413MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321437MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321468MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321505MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321512MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
G2231336220Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKCH2023-08-23