Reneurx

Primary DI
00860016212909
Brand
Reneurx
Company
Brixton Biosciences, Inc.
Model
BXT-SA-0629-US
Device description
BXT-SA-0629-US 5mL Reneurx Syringe
Published
2026-10-14
Public version status
New
Distribution status
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
SJAInjectable For Thermal Treatment Of Musculoskeletal Pain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SJAInjectable For Thermal Treatment Of Musculoskeletal Pain

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250067000ReneuRx™ (Neural Ice)Brixton Biosciences2026-08-21SJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016212923PackageGS14In Commercial Distribution
00860016212909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016212923008600162129238600162129230860016212923
00860016212909008600162129098600162129090860016212909

GMDN Terms#

Term, Definition table
TermDefinition
Prefilled syringe/needleA device consisting of a calibrated barrel (cylinder) with plunger and an attached needle, which is prefilled with a pharmaceutical (e.g., insulin, anti-rheumatic drug), intended to be used by a patient or carer for subcutaneous or intramuscular manual injection of a single dose of the medication/pharmaceutical; it is not intended for anaesthesia/nerve block. Procedural supportive devices (e.g., dressings, antiseptic wipes) may be included with the syringe. This is a single-use device.

Regulatory Flags#

DUNS number
117478005
Device count
1
DM exempt
false
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
false
Sterilization required before use
false