FDA.reportPublic FDA data

Symmetry Hibbs

Primary DI
00887482065273
Brand
Symmetry Hibbs
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
28-5220
Catalog number
28-5220
Device description
Symmetry® Gouge, Hibbs, Straight, 3/4 in Tip Width, 9 1/2 in, (20 mm)
Published
2022-09-08
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
GDHGouge, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482065273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482065273008874820652738874820652730887482065273

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9.5Inch

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
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811107954INKAThe Trustee for KAISER FAMILY TRUSTGDH2025-11-25
04026575033522Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033539Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033546Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033553Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033560Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033577Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
00190776408237MillenniumAvalign Technologies, Inc.GDH2025-08-07
00194613058371MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
00194613058395MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
00194613058678MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
04052536081066uCentumUlrich GmbH & Co. KGGDH2025-07-29
04052536081073uCentumUlrich GmbH & Co. KGGDH2025-07-29
04052536081080uCentumUlrich GmbH & Co. KGGDH2025-07-29
00840343726225GEN2SURGIX MEDICAL LLCGDH2025-05-08
00190776393199MillenniumAvalign Technologies, Inc.GDH2025-05-05
M9307591425310Life Instruments Life Instrument CorporationGDH2025-02-04
M9307591430310Life Instruments Life Instrument CorporationGDH2025-02-04
00190776390600MillenniumAvalign Technologies, Inc.GDH2024-11-19
00190776390617MillenniumAvalign Technologies, Inc.GDH2024-11-19
00190776387419MillenniumAvalign Technologies, Inc.GDH2024-11-08
00194613061043MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613061128MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613061869MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613062088MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613062095MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089184MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089191MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089207MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089399MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15