FDA.report

Hayden Medical

Primary DI
00840319727324
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
E7-2005
Catalog number
E7-2005
Device description
Air Injection 23ga, angled 7mm from bend to tip, 19mm overall length
Published
2022-08-10
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
HMXCannula, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840319727324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319727324008403197273248403197273240840319727324

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags

DUNS number
618214410
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
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

Primary DIBrandModelCatalogPublished
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319758571Hayden MedicalHM52501HM525012026-01-09
00840319758588Hayden MedicalHM52500-45/10HM52500-45/102026-01-09
00840319758595Hayden MedicalHM52500-45/5HM52500-45/52026-01-09
00840319758601Hayden MedicalHM52500-45HM52500-452026-01-09
00840319758533Hayden MedicalE1-1114E1-11142025-12-31
00840319758540Hayden MedicalE3-3646E3-36462025-12-31
00840319758557Hayden MedicalE3-2100E3-21002025-12-31
00840319758366Hayden MedicalE4-1532E4-15322025-12-24
00840319758373Hayden MedicalE4-1533E4-15332025-12-24
00840319758380Hayden MedicalE1-1084E1-10842025-12-24
00840319758397Hayden MedicalE5-6447TE5-6447T2025-12-24
00840319758403Hayden MedicalE3-2026E3-20262025-12-24
00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24
00840319758502Hayden Medical120-126D120-126D2025-12-24

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