FDA.report

BR Surgical, LLC

Primary DI
00840183526481
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR02-50581
Catalog number
BR02-50581
Device description
Queen square pattern Hammer, plastic flexible handle with round rubber head and reflex point, 13"
Published
2024-05-20
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
GWZPercussor

Product Code Classifications

CodeDeviceSpecialtyClass
GWZPercussorNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183526481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183526481008401835264818401835264810840183526481

GMDN Terms

TermDefinition
Percussion hammer, manual, reusableA hand-held manual instrument designed to be used by an examining physician to gently tap near a patient's joints to test reflexes (e.g., patellar, ankle reflexes). It consists of a handle and shaft typically made of stainless steel, and has a head that may be ring, wedge, or dome shaped and is made of a soft material (e.g., rubber or plastic). Some devices may be fitted with a spike, brush, or other detachable component at the proximal end that can be used for neurological examinations. This is a reusable device.

Sterilization Methods

Method

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
false
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
false

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