FDA.report

ELMED

Primary DI
00198506004476
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST3427510
Catalog number
ST3427510
Device description
SINSKEY MICRO IRIS HOOK BLUNT, .25MM TIP 10CM
Published
2024-04-26
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
HNQHook, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00198506004476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506004476001985060044761985060044760198506004476

GMDN Terms

TermDefinition
Ophthalmic surgical procedure kit, non-medicated, reusableA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. 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
true
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

Other Devices From This Company

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00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

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