FDA.reportPublic FDA data

ASSI

Primary DI
00841645125938
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AG112526
Device description
"Vienna Nasal Speculum 5 3/4"" 14.5cm Size 1, Std. Pattern, 30mm Bl."
Published
2020-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645125938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645125938008416451259388416451259380841645125938

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
055870299
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841645131991ASSIASSI.FOC178/752020-06-30
00841645119371ASSIASSI.125262020-06-25
00841645119425ASSIASSI.129262020-06-25
00841645103325ASSIASSI.FOAL2682016-09-26
00841645131830ASSIASSI.FOAE1632016-09-26
00841645131847ASSIASSI.FOAE1642016-09-26
00841645131854ASSIASSI.FOAE1652016-09-26
00841645131861ASSIASSI.FOAHL2802016-09-26
00841645131878ASSIASSI.FOAL2602016-09-26
00841645131885ASSIASSI.FOAL2612016-09-26
00841645131892ASSIASSI.FOAL2622016-09-26
00841645131908ASSIASSI.FOAL2662016-09-26
00841645131915ASSIASSI.FOAL2672016-09-26
00841645131922ASSIASSI.FOAL2712016-09-26
00841645131939ASSIASSI.FOC158/62016-09-26
00841645131946ASSIASSI.FOC158/752016-09-26
00841645131953ASSIASSI.FOC158/982016-09-26
00841645131960ASSIASSI.FOC171/62016-09-26
00841645131977ASSIASSI.FOC171/752016-09-26
00841645131984ASSIASSI.FOC171/982016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
G043608500BEARBear-Ent, LLCEPY2022-05-23
10381780503453Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503545Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780478591Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-18
10381780506300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-12
10381780506317Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-12
10381780403852Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780418993Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419006Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419228Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419235Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419280Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419297Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16