FDA.report

AccuTray™

Primary DI
20809160001643
Brand
AccuTray™
Company
MEDICAL ACTION INDUSTRIES INC.
Model
5200100
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OFTSpinal epidural anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160001643PackageGS124In Commercial Distribution
10809160001646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916000164320809160001643
1080916000164610809160001646

GMDN Terms

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.

Sterilization Methods

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

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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
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20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11
20809160512255MEDICAL ACTION INDUSTRIES846262026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956323443CARDINAL HEALTHCardinal Health 200, LLCOFT2026-02-09
04046955901197Combined Spinal & EpiduralB. BRAUN MEDICAL INC.OFT2026-02-03
50198956307795CARDINAL HEALTHCardinal Health 200, LLCOFT2025-12-31
20888277722276Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2025-12-18
50198956184037CARDINAL HEALTHCardinal Health 200, LLCOFT2025-08-27
40198459449063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
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40198459466411MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459467517MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11