FDA.reportPublic FDA data

CROWN SURGICAL

Primary DI
B92412183AM2
Brand
CROWN SURGICAL
Company
CROWN SURGICAL CORPORATION
Model
HEMOSTATS
Catalog number
12-183-AM
Device description
HALSTEAD Mosquito Forceps, Curved, 5" SATIN
Published
2020-12-31
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
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
B92412183AM2PackageHIBCC600In Commercial Distribution
B92412183AM0PrimaryHIBCC0
B92412183AM1Unit 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 neither intended for tissue manipulation nor 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
25
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
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
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
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10381780221739Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-03-22
10381780221753Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-03-22