FDA.reportPublic FDA data

CROWN SURGICAL

Primary DI
B92412188DB0
Brand
CROWN SURGICAL
Company
CROWN SURGICAL CORPORATION
Model
HEMOSTATS
Catalog number
12-188-DB
Device description
"KELLY Hemostatic Forceps, Straight, 5-1/2"""
Published
2021-02-27
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
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B92412188DB2PackageHIBCC300In Commercial Distribution
B92412188DB0PrimaryHIBCC0
B92412188DB1Unit 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
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
B924122010CROWN SURGICALHEMOSTATS12-2012021-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055250684Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250691Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250707Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250714Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259687Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259694Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259700Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259717Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259724Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259731Surgical DesignSurgical Design, Inc.HRQ2026-05-27
10193489456325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HRQ2022-08-04
ESAM3800121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3800141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3826141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3827141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3839141STOMA®Storz am Mark GmbHHRQ2020-08-27
10381780361022Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780361039Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780361046Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780385998Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-05-02
10381780024958Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780024972Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780025016Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780025061Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780221739Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-03-22
10381780221753Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-03-22