FDA.report

Dialator Nettle Ship

Primary DI
05060480407947
Brand
Dialator Nettle Ship
Company
BLINK MEDICAL LIMITED
Model
90-1012
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
HNWDilator, Lachrymal

Product Code Classifications

CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060480402447PackageGS110In Commercial Distribution
05060480407947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060480402447050604804024475060480402447
05060480407947050604804079475060480407947

GMDN Terms

TermDefinition
Lacrimal dilator, single-useA sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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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