FDA.report

Bausch + Lomb

Primary DI
00757770454402
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
ET9020
Catalog number
ET9020
Device description
RING FIXATION FINE-THORNTON 13
Published
2025-04-16
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

Related Records

Product Codes

CodeName
HNHRing, Ophthalmic (Flieringa)

Product Code Classifications

CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00757770454402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770454402007577704544027577704544020757770454402

GMDN Terms

TermDefinition
Flieringa ophthalmic ringA circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
196603781
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

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