FDA.reportPublic FDA data

ASSI

Primary DI
00841645132363
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.MTK1220014
Device description
Kocher Artery Forceps 14cm, Curved 1x2 teeth
Published
2020-06-30
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
EMDHemostat, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645132363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645132363008416451323638416451323630841645132363

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
G1493806608TBS DentalACME ENTERPRISE.EMD2026-03-02
G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
00841336101630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00841336101647Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726379GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726386GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726393GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
00842517111417Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517111424Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112209Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112216Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
D928140051190HEMOSTAT CRAFOORD SLIGHT CURVED 19CMW.H. Holden, Inc.EMD2024-12-18
00840343725099GEN2SURGIX MEDICAL LLCEMD2024-11-07
00840343724702GEN2SURGIX MEDICAL LLCEMD2024-10-25
00840343724061GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343724078GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343723255GEN2SURGIX MEDICAL LLCEMD2024-09-18
00840343723392GEN2SURGIX MEDICAL LLCEMD2024-09-12
00348783001440Premier HemostatPREMIER DENTAL PRODUCTS COMPANYEMD2024-08-01
00348783001457Premier HemostatPREMIER DENTAL PRODUCTS COMPANYEMD2024-08-01
00840343722913GEN2SURGIX MEDICAL LLCEMD2024-07-31
00840343722968GEN2SURGIX MEDICAL LLCEMD2024-07-31
00840343722999GEN2SURGIX MEDICAL LLCEMD2024-07-31
00813677023230PDT, Inc.PDT, INC.EMD2024-07-02
04049197054799RZ Medizintechnik GmbHRZ-Medizintechnik GmbHEMD2024-07-01
00840343722814GEN2SURGIX MEDICAL LLCEMD2024-06-28
04049197206495RZ Medizintechnik GmbHRZ-Medizintechnik GmbHEMD2024-06-28
04049197206693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHEMD2024-06-28