FDA.report

ELMED

Primary DI
00842180187207
Brand
ELMED
Company
ELMED INCORPORATED
Model
EL-OP7020-056
Catalog number
EL-OP7020-056
Device description
Bowman lacrimal probes. Double-ended. Straight tip. Silver. Overall length 5-1/2in (14cm). Sizes 5-6.
Published
2024-03-06
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
00842180187207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180187207008421801872078421801872070842180187207

GMDN Terms

TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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