DEPRESSOR

Primary DI
B974SD5000
Brand
DEPRESSOR
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
SCLERAL DEPRESSOR
Catalog number
SD500
Device description
SCHOCKERT DOUBLE-END SCLERAL DEPRESSOR SATIN 5-1/2
Published
2022-11-21
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
true

Related Records

Product Codes

CodeName
HNXDepressor, Orbital

Product Code Classifications

CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B974SD5000PrimaryHIBCC0

GMDN Terms

TermDefinition
Orbital depressor, single-useA 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 may be designed to be used with a light source (not included). 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. This is a single-use device.

Device Sizes

TypeValueUnit
Length5.5Inch

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
645680125
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
true
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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