Bradshaw Medical Inc. 5161-00-5056

GUDID 00810019932526

TLIF DISTRACTOR 5.5 / 6.0

Bradshaw Medical, Inc.

General internal orthopaedic fixation system implantation kit
Primary Device ID00810019932526
NIH Device Record Key9eb48a20-36f4-4d76-aa2f-2667385f52d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBradshaw Medical Inc.
Version Model Number5161-00-5056
Catalog Number5161-00-5056
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com
Phone2629251374
EmailCustomerService.KEN@intech-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810019932526 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


[00810019932526]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

On-Brand Devices [Bradshaw Medical Inc.]

00810019930003Large Ratchet, Large Axial, 1/4" Square Internal Adapter, Ø.180 Cannulation. Orange Silicone PM
00810019931390Large Ratchet, Palm Handle, 1/4" Square Internal Adapter, Ø.188 Cannulation. Silicone Color co
00810019931383BIT, SADDLE 6.0MM 1/4 SQ.
00810019931376BIT, SADDLE 5.0MM 1/4 SQ
00810019931369BIT, EXT. SCREW REMOVER 4.0MM 1/4 SQ
00810019931352BIT, EXT. SCREW REMOVER 3.5MM 1/4 SQ
00810019931345BIT, EXT. SCREW REMOVER 3.0MM 1/4 SQ
00810019931338BIT, EXT. SCREW REMOVER 2.5MM 1/4 SQ.
00810019931321BIT, INT.SCREW REMOVER 8.0MM 1/4 SQ
00810019931314BIT, INT.SCREW REMOVER 7.0MM 1/4 SQ
00810019931307BIT, INT.SCREW REMOVER 6.0MM 1/4 SQ
00810019931291BIT, INT.SCREW REMOVER 5.0MM 1/4 SQ
00810019931284BIT, INT.SCREW REMOVER 4.0MM 1/4 SQ
00810019931277BIT, CRUCIFORM 6.0MM 1/4 SQ
00810019931260BIT, CRUCIFORM 5.0MM 1/4 SQ
00810019931253BIT, PHILLIPS® #1 1/4 SQ
00810019931246BIT, BLADE LARGE .05" X .25" 1/4 SQ
00810019931239BIT, BLADE MEDIUM .04" X .22" 1/4 SQ
00810019931222BIT, BLADE SMALL .04" X .19" 1/4 SQ
00810019931215BIT, TREPHINE 8.0MM 1/4 SQ
00810019931208BIT, TREPHINE 7.0MM 1/4 SQ
00810019931192BIT, TREPHINE 6.0MM 1/4 SQ
00810019931185BIT, TREPHINE 5.0MM 1/4 SQ
00810019931178BIT, TREPHINE 4.0MM 1/4 SQ
00810019931161BIT, HEXALOBE 30 1/4 SQ
00810019931154BIT, HEXALOBE 27 1/4 SQ
00810019931147BIT, HEXALOBE 25 1/4 SQ
00810019931130BIT, HEXALOBE 20 1/4 SQ
00810019931123BIT, HEXALOBE 15 1/4 SQ
00810019931116BIT, HEXALOBE 12 1/4 SQ
00810019931109BIT, HEXALOBE 10 1/4 SQ
00810019931093BIT, HEX FEMALE 1/2 1/4 SQ
00810019931086BIT, HEX FEMALE 7/16 1/4 SQ
00810019931079BIT, HEX FEMALE 3/8 1/4 SQ
00810019931062BIT, HEX FEMALE 5/16 1/4 SQ
00810019931055BIT, HEX FEMALE 1/4 1/4 SQ
00810019931048BIT, HEX FEMALE 7/32 1/4 SQ
00810019931031BIT, HEX FEMALE 3/16 1/4 SQ
00810019931024BIT, HEX FEMALE 5/32 1/4 SQ
00810019931017BIT, HEX FEMALE 1/8 1/4 SQ
00810019931000BIT, HEX FEMALE 10MM 1/4 SQ
00810019930997BIT, HEX FEMALE 9.0MM 1/4 SQ
00810019930980BIT, HEX FEMALE 8.0MM 1/4 SQ
00810019930973BIT, HEX FEMALE 7.0MM 1/4 SQ
00810019930966BIT, HEX FEMALE 6.0MM 1/4 SQ
00810019930959BIT, HEX FEMALE 5.0MM 1/4 SQ
00810019930782BIT, EXT SCREW REMOVER 4.0MM AO
00810019930775BIT, EXT SCREW REMOVER 3.5MM AO
00810019930768BIT, EXT SCREW REMOVER 3.0MM AO
00810019930751BIT, EXT SCREW REMOVER 2.5MM AO

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