FDA.report

Bausch + Lomb

Primary DI
00757770425136
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E5100 10
Catalog number
E5100 10
Device description
DEPRESSOR SCLERAL MID
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
HNXDepressor, Orbital

Product Code Classifications

CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00757770425136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770425136007577704251367577704251360757770425136

GMDN Terms

TermDefinition
Orbital depressor, reusableA hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. It is usually made of metal. 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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