FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482111864
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
60-4077
Catalog number
60-4077
Device description
Symmetry® Blade, Trephine Eye, F/Castroviejo Corneal Transplant/Storz Universal Handle Peek, 7.75 mm, Square Ring, Single Use
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRHTrephine, Manual, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482111864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482111864008874821118648874821118640887482111864

GMDN Terms#

Term, Definition table
TermDefinition
Corneal trephine, reusableAn ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylinder, of different diameters, having a circular, saw-like working edge. It is an exchangeable device that may be attached to a manually rotated handle or to a powered rotary surgical handpiece. This device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887482196533Symmetry Barraquer60-1906-SYM60-1906-SYM2025-07-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158218468PRINCETONPrinceton Medical Group, Inc.HRH2026-01-15
00852194002106HAI TrephineHightech American Industrial Labs IncHRH2025-12-16
00757770422494Bausch + LombBausch & Lomb IncorporatedHRH2025-08-08
00194613037956MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00194613111380MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00757770435432Bausch + LombBausch & Lomb IncorporatedHRH2025-07-30
G412PH98270MR PHACOCrestpoint Management LimitedHRH2025-06-09
G412PH62270MR PHACOCrestpoint Management LimitedHRH2025-05-27
05056100712935Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712942Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712799Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713079Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712959Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712966Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712973Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712980Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712997Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713000Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713017Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713024Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712898Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713048Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713055Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713062Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
00757770430345Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00757770435036Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00757770455867Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00192896120235Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120242Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120259Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15