FDA.report

Seibel Capsulorhexis Forceps with Viewport, 23g Single Use

Primary DI
00844685006922
Brand
Seibel Capsulorhexis Forceps with Viewport, 23g Single Use
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
DFH-1030-1
Catalog number
DFH-1030-1
Published
2018-09-18
Public version status
Update
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
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844685006922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685006922008446850069228446850069220844685006922

GMDN Terms

TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, single-useA sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. 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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