FDA.reportPublic FDA data

ACCUTRAY¿

Primary DI
20809160001568
Brand
ACCUTRAY¿
Company
MEDICAL ACTION INDUSTRIES INC.
Model
5200048
Published
2016-08-26
Public version status
Update
Distribution status
Not 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
OFTSpinal epidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160001568PackageGS124Not in Commercial Distribution
10809160001561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916000156820809160001568
1080916000156110809160001561

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. 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
true
HCT/P
false
Kit
true
Combination product
true
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
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
10809160016770Medical Action Industries718912016-08-20
10809160394052Medical Action Industries833482023-02-09
10809160435038Medical Action Industries838262024-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489437966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-07-29
10193489211931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489213485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214468Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215373Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215878Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489216233Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489412222Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489413717Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489417821Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489418057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489419092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422313Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422344Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489423396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425277Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489429909Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489441420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489441604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445398Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489445527Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08