FDA.reportPublic FDA data

American Medicals

Primary DI
B356111PL84312ST1
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356111PL84312ST1PackageHIBCC25In Commercial Distribution
B356111PL84312ST0PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
109909627
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B35675400020American Medicals12026-05-20
B35675440110American Medicals12026-05-20
B356BH414050American Medicals12026-05-06
B356KB074090American Medicals12026-05-06
B356KF251020American Medicals12026-04-15
B356KF251040American Medicals12026-04-15
B356ED469970American Medicals12026-04-07
B356ED470040American Medicals12026-04-07
B356ED470050American Medicals12026-04-07
B356JD259280American Medicals12026-03-09
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10
B356FH455060American Medicals12025-12-10
B356ED107160American Medicals12025-12-03
B356JB536280American Medicals12025-11-25
B356BK211150American Medicals12025-11-10
B356DF410180American Medicals12025-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488153Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488139Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111488160Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111062698Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-11
10649111062957Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-10
10649111063268Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063541Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111487798Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111487835Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063879Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-28
10649111487897Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-28
10649111064579Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111064791Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111065439Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111487828Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111065644Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111066344Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111488054Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111077661Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-21