FDA.reportPublic FDA data

Symmetry Kirby

Primary DI
00887482107867
Brand
Symmetry Kirby
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-1285
Catalog number
60-1285
Device description
Symmetry® Loop, Kirby Intra-Capsular Lens, 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
00887482107867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482107867008874821078678874821078670887482107867

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
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21
10840113233066BovieAA04X2026-09-21
10840113233080BovieAA052026-09-21
10840113233165BovieAA212026-09-21
10840113233189BovieAA21X2026-09-21
10840113233264BovieAA902026-09-21
10840113233547BovieAA05X2026-09-21
10840113234407BovieES232026-09-21
10840113234414BovieES22-82026-09-21
10840113236838BovieES032026-09-21
10840113236845BovieES022026-09-21
10840113236852BovieES02T2026-09-21
10840113236876BovieES012026-09-21

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
00757770410019Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410286Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410965Bausch + 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
00757770413706Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
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00757770417384Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417759Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
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00757770420261Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
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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