FDA.report

Synergetics

Primary DI
20841305111978
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
39.32.23PIN
Catalog number
39.32.23PIN
Device description
Pinnacle 360°™ 23ga Reddy End Grasping Forceps
Published
2019-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20841305111978PackageGS15In Commercial Distribution
10841305111964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2084130511197820841305111978
1084130511196410841305111964

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
021056726
Device count
1
DM exempt
true
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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20841305107988Synergetics30.9030.902020-09-18
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