FDA.reportPublic FDA data

Symmetry Bunnell

Primary DI
00887482125229
Brand
Symmetry Bunnell
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
76-5110
Catalog number
76-5110
Device description
Symmetry® Drill, Bunnell Hand, 5 1/2 in
Published
2024-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBDHandpiece (Brace), Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBDHandpiece (Brace), DrillNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482125229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482125229008874821252298874821252290887482125229

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586N6871060Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N6872220Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761800Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761810Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761820Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
G586N8761880Novo SurgicalNOVO SURGICAL, INC.HBD2023-12-18
00190776375553MillenniumAvalign Technologies, Inc.HBD2023-09-08
00842331168611Novo Surgical Inc. NOVO SURGICAL, INC.HBD2022-11-13
00842331130731Novo Surgical Inc. NOVO SURGICAL, INC.HBD2022-11-10
00842331136108Novo Surgical Inc. NOVO SURGICAL, INC.HBD2022-11-10
04038653068821MACRO-LINEAesculap AGHBD2020-08-24
04038653069460AESCULAPAesculap AGHBD2020-05-08
04038653162956AESCULAPAesculap AGHBD2020-04-22
10381780494997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-10-24
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M2742951161Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-04-02
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M2742751351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
M2742951111Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31
M2742951171Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBD2018-01-31