FDA.report

BR Surgical, LLC

Primary DI
00840183521998
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR42-32814
Catalog number
BR42-32814
Device description
SCHOCKET scleral depressor w/ pocket clip, double-ended
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNXDepressor, Orbital

Product Code Classifications

CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183521998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183521998008401835219988401835219980840183521998

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
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
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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