FDA.report

Lac. Probe

Primary DI
00841668119686
Brand
Lac. Probe
Company
KATENA PRODUCTS, INC.
Model
08-09122
Catalog number
08-09122
Device description
Bowman Lacrimal Probe, Size 0000-000
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HNLProbe, lachrymal

Product Code Classifications

CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668119686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668119686008416681196868416681196860841668119686

GMDN Terms

TermDefinition
Lacrimal probe, reusableA hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags

DUNS number
085668598
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00841668146095BLINK60-500860-50082026-03-23
00841668146101BLINK60-500960-50092026-03-23
00841668146118BLINK60-502560-50252026-03-23
00841668146125BLINK60-502660-50262026-03-23
00841668146132BLINK60-503060-50302026-03-23

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