FDA.report

AVID TruCustom

Primary DI
20809160211554
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
SHER010-12_0003
Catalog number
SHER010-12
Published
2018-10-05
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

Related Records

Contact Domains

Product Codes

CodeName
OGJNerve block tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160211554PackageGS12Not in Commercial Distribution
10809160211557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916021155420809160211554
1080916021155710809160211557

GMDN Terms

TermDefinition
Neurosurgical procedure kit, medicatedA collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888) 564-7153AVIDComplaints@Owens-Minor.com

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
false

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