FDA.report

Bausch + Lomb

Primary DI
00757770535545
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
ET1005
Catalog number
ET1005
Device description
CUNNINGHAM MEIBOMIAN EXPRESSOR
Published
2024-11-20
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
HNSExpressor

Product Code Classifications

CodeDeviceSpecialtyClass
HNSExpressorOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00757770535545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770535545007577705355457577705355450757770535545

GMDN Terms

TermDefinition
Eye muscle hook, reusableA hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. 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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