FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183526962
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR68-25019
Catalog number
BR68-25019
Device description
PRATT Rectal Probe, with sterling shaft, 8"
Published
2024-05-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXXProbe, Rectal, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXXProbe, Rectal, Non-PoweredGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183526962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183526962008401835269628401835269620840183526962

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531065BR Surgical, LLCBR08-36111SCSBR08-36111SCS2025-09-29
00840183531089BR Surgical, LLCBR18-48273BR18-482732025-09-29
00840183531133BR Surgical, LLCBR12-32114BR12-321142025-09-29
00840183531171BR Surgical, LLCBR18-15003BR18-150032025-09-29
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613026622MSI Precision Specialty InstrumentsMed Saver, Inc.EXX2025-08-01
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04049047024477GimmiGimmi GmbHEXX2025-04-16
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00840306830341Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
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00840306830365Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306826832Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-05-10
00840306824166Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-29
00840306821684Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306821691Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306806728Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
00840306807336Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
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00860001161618GreenEggEndoglow, LLCEXX2023-07-07
00840306808258Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00840306808326Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00842331181887Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331185564Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331152450Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331155468Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331131493Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331133619Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331135583Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331136306Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10