FDA.report

Conjunctival Probe

Primary DI
05060480408647
Brand
Conjunctival Probe
Company
BLINK MEDICAL LIMITED
Model
CP01
Published
2022-06-30
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
HNDSpatula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060480402898PackageGS110In Commercial Distribution
05060480408647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060480402898050604804028985060480402898
05060480408647050604804086475060480408647

GMDN Terms

TermDefinition
Conjunctival trocar bladeA rigid, hand-held, manual ophthalmic surgical instrument with a sharp tip intended to puncture and create an opening in the conjunctiva, typically to facilitate a sub-Tenon’s block with a local anaesthetic agent. It is typically used as an alternative to conjunctival scissors. It is not intended to fill the lumen of an ophthalmic cannula and is not designed for transscleral access. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
738288096
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
false
Sterilization required before use
false

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