FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799039828
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
SSD7 1085
Catalog number
SSD7 1085
Device description
Stevens Tenotomy Scissors, Straight, Single Use, 10/Box
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNFSCISSORS, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799039828PackageGS110In Commercial Distribution
00810799039835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799039828008107990398288107990398280810799039828
00810799039835008107990398358107990398350810799039835

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, single-useA hand-held manual ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or sprung handles, and is available with various blade designs and sizes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(859)259-4925info@stephensinst.com

Regulatory Flags#

DUNS number
081853285
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810061912194Stephens Instruments S5-1612S5-16122025-07-23
00810061912606Stephens Instruments S5-1921S5-19212025-07-23
00810061912613Stephens Instruments ST5-1246ST5-12462025-07-23
00810061912620Stephens Instruments ST5-1614ST5-16142025-07-23
00810061910435Stephens InstrumentsST5-7000-23ST5-7000-232020-09-23
00810061910442Stephens InstrumentsST5-7000-25ST5-7000-252020-09-23
00810061910459Stephens InstrumentsST5-7005-23ST5-7005-232020-09-23
00810061910466Stephens InstrumentsST5-7005-25ST5-7005-252020-09-23
00810061910473Stephens InstrumentsST5-7010-23ST5-7010-232020-09-23
00810061910480Stephens InstrumentsST5-7010-25ST5-7010-252020-09-23
00810061910497Stephens InstrumentsST5-7035ST5-70352020-09-23
00810061910510Stephens InstrumentsST5-7050ST5-70502020-09-23
00810061910541Stephens InstrumentsST5-7065ST5-70652020-09-23
00810061910558Stephens InstrumentsST5-7070ST5-70702020-09-23
00810061910503Stephens InstrumentsST5-7040ST5-70402020-09-22
00810061910527Stephens InstrumentsST5-7056ST5-70562020-09-22
00810061910534Stephens InstrumentsST5-7060ST5-70602020-09-22
00810799032928Stephens InstrumentsS4-1490S4-14902020-09-22
00810799031358Stephens InstrumentsS2-1131S2-11312020-09-22
00810799031365Stephens InstrumentsS2-1135S2-11352020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439828MilleniumAvalign Technologies, Inc.HNF2026-10-28
B382SD9039901000Surgical DirectSurgical Direct, Inc.HNF2026-10-28
G346ED1010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-10-28
00724995315870V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315887V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315894V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315917V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315924V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315931V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315948V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315955V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315962V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315979V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315986V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315993V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316006V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316013V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316501V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316518V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316525V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316570V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316587V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316594V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316600V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316655V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316693V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316709V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316716V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316723V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316730V. MuellerSTERIS Deutschland GmbHHNF2026-10-27