FDA.report

Surgical Direct

Primary DI
B382S340782000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S34078.200
Catalog number
S34078.200
Device description
4 1/2" Lester IOL Manipulator Angled, With Round Knurled Handle, 9mm From Tip To
Published
2023-08-30
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
HNDSpatula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382S340782000PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(386) 738-1202info@surgicaldirect.com

Regulatory Flags

DUNS number
124367223
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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