FDA.report

MST Capsule Retractor, Chang Modification

Primary DI
00844685006328
Brand
MST Capsule Retractor, Chang Modification
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
MCR-0002-1
Catalog number
MCR-0002-1
Published
2018-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HNIRetractor, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844685006328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685006328008446850063288446850063280844685006328

GMDN Terms

TermDefinition
Intraocular retractor, single-useA sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
097824130
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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