FDA.reportPublic FDA data

CROWN SURGICAL

Primary DI
B92415268DB0
Brand
CROWN SURGICAL
Company
CROWN SURGICAL CORPORATION
Model
CLAMPS
Catalog number
15-268-DB
Device description
"VORSE (U.S. Pattern) Tube Occluding Clamp, Straight, Serrated, 7-1/2"""
Published
2021-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B92415268DB2PackageHIBCC264In Commercial Distribution
B92415268DB0PrimaryHIBCC0
B92415268DB1Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, single-useA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
15162927400MIRZA@FINESURGICAL.COM

Regulatory Flags#

DUNS number
645681094
Device count
12
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B92402447DB0CROWN SURGICALFORCEPS02-447-DB2020-12-31
B924121800CROWN SURGICALHEMOSTATS12-1802021-02-28
B924121810CROWN SURGICALHEMOSTATS12-1812021-02-28
B924121820CROWN SURGICALHEMOSTATS12-1822021-02-28
B92412182AM0CROWN SURGICALHEMOSTATS12-182-AM2020-12-31
B92412182FP0CROWN SURGICALHEMOSTATS12-182-FP2021-01-30
B92412182S0CROWN SURGICALHEMOSTATS12-182-S2020-12-31
B924121830CROWN SURGICALHEMOSTATS12-1832021-02-28
B92412183AM0CROWN SURGICALHEMOSTATS12-183-AM2020-12-31
B92412183DB0CROWN SURGICALHEMOSTATS12-183-DB2021-02-28
B92412183FP0CROWN SURGICALHEMOSTATS12-183-FP2021-01-30
B924121880CROWN SURGICALHEMOSTATS12-1882021-03-05
B92412188DB0CROWN SURGICALHEMOSTATS12-188-DB2021-02-27
B924121890CROWN SURGICALHEMOSTATS12-189-DB2021-02-27
B92412189DB0CROWN SURGICALHEMOSTATS12-189-DB2020-12-31
B924121910CROWN SURGICALHEMOSTAT12-1912020-12-31
B924121920CROWN SURGICALHEMOSTATS12-1922021-02-28
B924121940CROWN SURGICALHEMOSTATS12-1942021-02-28
B924122000CROWN SURGICALHEMOSTATS12-1922021-02-28
B92412200DB0CROWN SURGICALHEMOSTATS12-200-DB2021-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849771050374NAKEY SURGICAL, INC.GDJ2023-03-31
G25003048090Backhaus Towel Forceps 9cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048110Backhaus Towel Forceps 11cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048130Backhaus Towel Forceps 13cmN S SURGICAL COMPANYGDJ2023-01-31
10849771050381NAKEY SURGICAL, INC.GDJ2023-01-26
10849771050398NAKEY SURGICAL, INC.GDJ2023-01-26
14026704789570PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789662PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789679PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791160PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791177PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791184PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791191PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791276PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791283PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791290PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791306PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791566PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791573PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791634PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
10886982311146NASynthes GmbHGDJ2022-11-29
10886982311153NASynthes GmbHGDJ2022-11-29
10886982311160NASynthes GmbHGDJ2022-11-29
10886982311177NASynthes GmbHGDJ2022-11-29
ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15
ESOT002462NAS & T AGGDJ2022-09-15
ESOT002862NAS & T AGGDJ2022-09-15
ESOT002871NAS & T AGGDJ2022-09-15