FDA.report

Epsilon USA

Primary DI
G346EN04L0
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
EN-04L
Device description
Curved Needle Holder Without Lock(130 mm Overall) Titanium
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications

CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G346EN04L0PrimaryHIBCC0

GMDN Terms

TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts

PhoneEmail
(909) 984-4614epsilonusa1@gmail.com

Regulatory Flags

DUNS number
917922762
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
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

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G346EEN0132Epsilon USAEEN-013-22025-12-17
G346ERF12C0Epsilon USAERF-12C2025-11-24
G346ESF03SS0Epsilon USAESF-03SS2025-11-13
G346EP55L0Epsilon USAEP-55L2025-09-26
G346EP1650Epsilon USAEP-1652025-09-23
G346EC222SS0Epsilon USAEC-222 SS2025-09-18
G346EP98SS0Epsilon USAEP-98SS2025-09-03
G34EP223L0Epsilon USAEP-223L2025-08-13
G346EA01L212521GSS0Epsilon USAEA-01L25-21GSS2025-08-08
G346EC208Epsilon USAEC-2082025-07-07
G346ECF54SS0Epsilon USAECF-54SS2025-07-07

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