FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183530396
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR981-01039
Catalog number
BR981-01039
Device description
"Instrument tape roll, green, 1/4"" x 250"""
Published
2025-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183530396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183530396008401835303968401835303960840183530396

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument track identification tapeA non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531058BR Surgical, LLCBR46-39002BR46-390022026-07-17
00840183531546BR Surgical, LLCBR08-34411LBR08-34411L2026-07-17
00840183531553BR Surgical, LLCBR08-28118-LBR08-28118-L2026-07-17
00840183531577BR Surgical, LLCBR09-10212BR09-102122026-07-17
00840183531614BR Surgical, LLCBR08-34109SCBR08-34109SC2026-07-17
00840183531645BR Surgical, LLCBR08-93523BR08-935232026-07-17
00840183531706BR Surgical, LLCBR08-43518BR08-435182026-07-17
00840183532406BR Surgical, LLCBR08-31012SCBR08-31012SC2026-07-17
00840183532413BR Surgical, LLCBR08-82113SCBR08-82113SC2026-07-17
00840183532963BR Surgical, LLCBR46-43414BR46-434142026-07-17
00840183532970BR Surgical, LLCBR46-43415BR46-434152026-07-17
00840183531591BR Surgical, LLCBR04-19017BR04-190172026-07-16
00840183531690BR Surgical, LLCBR04-13010BR04-130102026-07-16
00840183531850BR Surgical, LLCBR08-23323BR08-233232026-07-16
00840183531966BR Surgical, LLCBR08-27015BR08-270152026-07-16
00840183532635BR Surgical, LLCBR04-17024BR04-170242026-07-16
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183529000BR Surgical, LLCBR900-5050-OLYSTZBR900-5050-OLYSTZ2024-11-07
00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23

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Primary DI, Brand, Company table
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