FDA.report

BR Surgical, LLC

Primary DI
00840183525477
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR50-29003
Catalog number
BR50-29003
Device description
TONSIL SYRINGE, 3-ring, Luer-lock, 3ml
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KCPSyringe, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183525477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183525477008401835254778401835254770840183525477

GMDN Terms

TermDefinition
General-purpose syringe, reusableA non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); it is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment of the female connector (hub) of a hypodermic needle or an administration set. It is typically made of glass and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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