FDA.reportPublic FDA data

CROWN SURGICAL

Primary DI
B92416285A0
Brand
CROWN SURGICAL
Company
CROWN SURGICAL CORPORATION
Model
NEEDLE HOLDER
Catalog number
16-285-A
Device description
"BAUMGARTNER Needle Holder, Serrated, 5-1/2"""
Published
2021-01-30
Public version status
New
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B92416285A0PrimaryHIBCC0
B92416285A1Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. 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
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
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621855Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621862Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621879Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621886Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621893Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621909Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621916Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621923Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621930Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621947Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621954Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621961Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621978Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
G45313110753150PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-05-06
G4254202900My MedicalMy Medical Store LLCFHQ2026-05-04
G4254203160My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209120My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209140My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209170My MedicalMy Medical Store LLCFHQ2026-02-17
G45313110845130PEAK MEDICALPeak Medical Distribution Inc.FHQ2023-07-03
G25004025180Tungsten Carbide Debakey Needle Holder 18cmN S SURGICAL COMPANYFHQ2023-01-27