FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183500528
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR70-40057
Catalog number
BR70-40057
Device description
Cervical Dilator Set, sizes 1mm, 1.5mm, 2mm, 2.5mm, 3mm, interchangeable handle, stainless steel
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183500528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183500528008401835005288401835005280840183500528

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
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00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
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00348783011272Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
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00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
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04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
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