FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799035585
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S5-1995
Catalog number
S5-1995
Device description
Kerrison Rongeur Forceps, Size 2
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNGRongeur, lachrymal sac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNGRongeur, Lachrymal SacOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799035585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799035585008107990355858107990355850810799035585

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081853285
Device count
1
Premarket exempt
true
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
04058935012762Belz Lacrimal Sac RongeurBausch & Lomb GmbHHNG2025-07-10
00757770404476Bausch + LombBausch & Lomb IncorporatedHNG2024-11-20
00850048576063Intacs Pocketing HookADDITION TECHNOLOGY, INC.HNG2023-06-13
00810799035554Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035561Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035578Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035592Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00841668108475RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108482RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108499RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108505RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108512RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108529RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00840159903339RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01
00840159907856RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01