FDA.report

Medical Action Industries

Primary DI
20809160023843
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
56444
Published
2016-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KCGDILATOR, TRACHEAL

Product Code Classifications

CodeDeviceSpecialtyClass
KCGDilator, TrachealEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160023843PackageGS150Not in Commercial Distribution
10809160023846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916002384320809160023843
1080916002384610809160023846

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods

Method

Regulatory Flags

DUNS number
092364462
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
20809160517113MEDICAL ACTION INDUSTRIES843992026-03-23
20809160516574Medical Action Industries82274B2026-03-19
20809160016463Medical Action Industries716912016-08-20
20809160515195Clear Sequence836992026-03-06
20809160515218MEDICAL ACTION INDUSTRIES848602026-03-06
20809160515157MEDICAL ACTION INDUSTRIES847242026-03-05
20809160514938Medical Action Industries81329E2026-03-04
20809160514990Medical Action Industries76567F2026-03-04
20809160515003Medical Action Industries78304B2026-03-04
20809160515027Medical Action Industries77156B2026-03-04
20809160514754MEDICAL ACTION INDUSTRIES82438B2026-03-03
20809160514761MEDICAL ACTION INDUSTRIES82436B2026-03-03
20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
20809160513924MEDICAL ACTION INDUSTRIES848192026-02-25
20809160513337MEDICAL ACTION INDUSTRIES82274C2026-02-20
20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

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00840183513764BR Surgical, LLCBR Surgical, LLCKCG2024-06-10
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10381780086499Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKCG2018-10-24
10381780086505Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKCG2018-10-24
00888118054579DILATORKLS-Martin L.P.KCG2018-09-26
00888118054586DILATORKLS-Martin L.P.KCG2018-09-26