FDA.reportPublic FDA data

Symmetry Lewis

Primary DI
00887482041369
Brand
Symmetry Lewis
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-1276
Catalog number
60-1276
Device description
Symmetry® Loop, Lewis Lens, Large, 5 1/2 in
Published
2024-08-15
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
HNESnare, Enucleating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNESnare, EnucleatingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482041369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482041369008874820413698874820413690887482041369

GMDN Terms#

Term, Definition table
TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. 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
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
00757770417810Bausch + LombBausch & Lomb IncorporatedHNE2024-11-19
00757770403042Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770403684Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770403950Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770404568Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770405701Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770407149Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770408511Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410019Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410286Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410965Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411092Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411252Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411696Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411993Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413065Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413126Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413706Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770415205Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417384Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417759Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420216Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420261Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420537Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421084Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421763Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421978Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770422449Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423262Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423477Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26