Removal Driver, T15

GUDID 00840118115117

surgical instrument or accessory for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Surgical screwdriver, single-use, sterile
Primary Device ID00840118115117
NIH Device Record Key2cd18155-ade5-4068-b64a-94e8ef6dc071
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemoval Driver, T15
Version Model NumberRMD 200
Company DUNS078790947
Company NameFLOWER ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118115117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-24
Device Publish Date2019-06-14

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

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00840118125475 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 29mm
00840118125482 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 30mm
00840118125499 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 31mm
00840118125505 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 32mm
00840118125512 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 33mm
00840118125529 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 34mm
00840118125536 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 35mm

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