FDA.reportPublic FDA data

MEDICAL ACTION INDUSTRIES

Primary DI
20809160355630
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
81891
Published
2021-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970889000ULTRASOUND TRANSDUCER DRAPEProtek Medical Products, Inc.1997-10-20KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160355630PackageGS120In Commercial Distribution
10809160355633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916035563020809160355630
1080916035563310809160355633

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, image-enhancementA non-sterile sheath containing an extraluminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10809160520468Medical Action Industries771202026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29