AVID TruCustom

Primary DI
20809160096007
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
SLHS019-01_0001
Published
2016-09-14
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
OGDCustom anesthesia tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160096007PackageGS13In Commercial Distribution
10809160096000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916009600720809160096007
1080916009600010809160096000

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
Ethylene Oxide

Regulatory Flags

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
true

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