FDA.reportPublic FDA data

ASSI

Primary DI
00841645135708
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.SU52426
Device description
Sheath w/ 1 Fixed Stop Cock, 17.5cm 4mm dia., w/ Non-Glare Satin Finish
Published
2020-07-10
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

Product Codes#

Code, Name table
CodeName
FBMCannula And Trocar, Suprapubic, Non-Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBMCannula And Trocar, Suprapubic, Non-DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645135708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645135708008416451357088416451357080841645135708

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
055870299
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841645143215ASSIASSI.BPNS243252023-08-18
00841645143222ASSIASSI.BPNS153392023-08-18
00841645142843ASSIASSI.SU632262023-08-11
00841645104988ASSIASSI.ACC1VB2023-08-11
00841645105091ASSIASSI.R1A2023-08-11
00841645105107ASSIASSI.ACC11AB2023-08-11
00841645105176ASSIASSI.DC1VB2023-08-11
00841645107385ASSIASSI.BS18822023-08-11
00841645108412ASSIASSI.005822023-08-11
00841645108474ASSIASSI.158842023-08-11
00841645108498ASSIASSI.16252023-08-11
00841645108542ASSIASSI.16632023-08-11
00841645108573ASSIASSI.16672023-08-11
00841645108634ASSIASSI.17002023-08-11
00841645108665ASSIASSI.17342023-08-11
00841645108696ASSIASSI.17402023-08-11
00841645108733ASSIASSI.17682023-08-11
00841645108771ASSIASSI.18002023-08-11
00841645108795ASSIASSI.18022023-08-11
00841645108856ASSIASSI.18322023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08403207004482Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004499Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004505Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004512Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004529Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004536Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004543Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
00842962130278HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130285HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130292HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130308HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130315HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962109052HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109069HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109076HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109083HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109090HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109106HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109113HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109021HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109038HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109045HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842331178023Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-14
00842331150944Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-12
00842331144011Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-11
00190660173449Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173456Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173463Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173470Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173487Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04