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Stephens Instruments

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref S5-1325

by Krishna Imports Inc

Identity

Trade Name
Stephens Instruments FDA UDI
Generic Name
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
Device Name
Hess Iris Forceps, Very Delicate, 1X2 Teeth EUDAMED
Hess Iris Forceps, 1x2 Teeth FDA UDI
Model / Reference
S5-1325 EUDAMEDFDA UDI
Description
Hess Iris Forceps, 1x2 Teeth FDA UDI

Identifiers

Catalog Number
S5-1325 FDA UDI
Primary DI / UDI-DI
00810799033994 EUDAMEDFDA UDI
Basic UDI-DI
B-00810799033994 EUDAMED
FDA Product Code
HNR FDA UDI
EMDN Code
L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
GMDN Term
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
886.4350 FDA UDI
Market of Registration
Norway EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Stephens Instruments by Krishna Imports Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Krishna Imports Inc

Sources (2)

  • FDA UDI f71165d7-1086-41ba-beec-11942d687e9a 36 fields · synced Jul 12, 2026
  • EUDAMED ab284746-dffd-4470-bef4-58fe13e9275a 61 fields · synced Jul 12, 2026