DILATOR 3

GUDID 00810019931567

A dilator, in this context, is a surgical instrument used to create and progressively expand a working channel or surgical corridor through soft tissue to reach a deeper anatomical target, such as the spine.

Bradshaw Medical, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810019931567
NIH Device Record Keyc9d45552-21bf-4b8a-8bcd-23bac5a443f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDILATOR 3
Version Model NumberMRS-107-3
Company DUNS621830582
Company NameBradshaw Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810019931567 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


[00810019931567]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-18
Device Publish Date2025-08-08

Devices Manufactured by Bradshaw Medical, Inc.

00810019931574 - Concentrical blade - length 50 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931598 - Concentrical blade - length 70 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931604 - Concentrical blade - length 80 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931628 - Concentrical blade - length 90 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931635 - Concentrical blade - length 100 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931642 - Concentrical blade - length 110 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931659 - Concentrical blade - length 120 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
00810019931666 - Concentrical blade - length 130 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.