FDA.report

Retinal Tip 25G Microforceps end-gripping

Primary DI
08058340228389
Brand
Retinal Tip 25G Microforceps end-gripping
Company
AKTIVE SRL
Model
AK-1671
Catalog number
AK-1671
Device description
Retinal Tip 25G Microforceps end-gripping
Published
2024-01-11
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
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08052276028204PrimaryGS10
08058340228389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08052276028204080522760282048052276028204
08058340228389080583402283898058340228389

GMDN Terms

TermDefinition
Ophthalmic soft-tissue surgical forceps probe-tip, single-useA sterile distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
433533053
Device count
5
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
false
Sterilization required before use
false

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