FDA.reportPublic FDA data

CROWN SURGICAL

Primary DI
B92412189DB0
Brand
CROWN SURGICAL
Company
CROWN SURGICAL CORPORATION
Model
HEMOSTATS
Catalog number
12-189-DB
Device description
"KELLY Hemostatic Forceps, Curved, 5-1/2"""
Published
2020-12-31
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
B92412189DB2PackageHIBCC300In Commercial Distribution
B92412189DB0PrimaryHIBCC0
B92412189DB1Unit 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
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
00810143909197SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909265SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909302SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909616SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931777SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931784SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931791SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931807SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931814SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931906SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931920SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931937SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931944SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931951SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931968SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212935089SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143907438SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908725SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908732SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908749SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908756SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909722SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909739SURGIPROSSurgipros, LLCHRQ2026-07-30
00840183532321BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00840183533076BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00810055258567Surgical DesignSurgical Design, Inc.HRQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.HRQ2026-06-22
05060212051103Crile Artery Forceps, 145mm StraightDTR MEDICAL LIMITEDHRQ2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatDTR MEDICAL LIMITEDHRQ2026-06-10
05060411984639Baby Overholt Artery Forceps Curved, 140mmDTR MEDICAL LIMITEDHRQ2026-06-10