FDA.reportPublic FDA data

Symmetry Lewis

Primary DI
00887482107829
Brand
Symmetry Lewis
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-1277
Catalog number
60-1277
Device description
Symmetry® Loop, Lewis Lens
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
00887482107829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482107829008874821078298874821078290887482107829

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.

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
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04
00840113233465BovieH1112026-09-04
00840113233489BovieH1122026-09-04
00840113233502BovieH1212026-09-04
00840113233526BovieHISL2026-09-04
00840113237326BovieESP1N2026-09-04
00840113237340BovieESP1H2026-09-04
00840113237593BovieESP7N2026-09-04
00840113237623BovieESP7H2026-09-04
00840113237661BovieESP6N2026-09-04
00840113237692BovieESP6H2026-09-04
00840113242573BovieST052026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00757770410286Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
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00757770411696Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411993Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413065Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413126Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
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00757770422449Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423262Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423477Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26