FDA.report

Symmety Surgical

Primary DI
00887482000328
Brand
Symmety Surgical
Company
SYMMETRY SURGICAL INC.
Model
15-1006
Catalog number
15-1006
Device description
Burr
Published
2016-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HBGDrills, Burrs, Trephines & Accessories (Manual)

Product Code Classifications

CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887482000328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482000328008874820003288874820003280887482000328

GMDN Terms

TermDefinition
Manual cranial rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

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00887482196540Symmetry Castroviejo60-1910-SYM60-1910-SYM2025-07-24
00887482012307Symmetry Tyrell 38-652538-65252022-09-16
00887482006559Symmetry Surgical32-348532-34852024-09-05
00887482006566Symmetry Surgical32-348532-34852024-09-05
00887482196793Symmetry Surgical90-1042R90-1042R2024-09-05
00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

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10381780537335Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
10381780537342Integra®INTEGRA PAIN MANAGEMENTHBG2024-11-19
G2843520100Drill BitNeurovention LLCHBG2024-10-17
00887482000892Symmetry Surgical®SYMMETRY SURGICAL INC.HBG2024-08-07
00842962140079HNM MEDICALHNM STAINLESS, LLC.HBG2023-04-02
00842962140086HNM MEDICALHNM STAINLESS, LLC.HBG2023-04-02
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00850359007959SmartTipCLEARPOINT NEURO, INC.HBG2021-04-07
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00850359007348SmartTwistCLEARPOINT NEURO, INC.HBG2021-01-22
00850359007355SmartTipCLEARPOINT NEURO, INC.HBG2021-01-22
00850359007362SmartTipCLEARPOINT NEURO, INC.HBG2021-01-22
10381780514749CODMAN® GHAJAR GUIDEINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-04-01
10381780514701CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-02-28
10381780514718CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2020-02-28
M711LS4250Neuro & Craniofacial Fixation SystemINNO Holdings, Inc.HBG2018-08-13
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M274RB21241Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21251Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21281Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21291Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21301Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29
M274RB21311Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-12-29