FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158217461
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
25150-14
Device description
"NEEDLE HOLDER BAUMGARTNER SERRATED 5"""
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810158217461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158217461008101582174618101582174610810158217461

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It 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. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012857277
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810158219762PRINCETON11116-182026-05-20
00810158219779PRINCETON19995-382026-05-20
00810158219786PRINCETON89139-172026-05-20
00810158219793PRINCETON33654-102026-05-20
00810158219809PRINCETON45206-162026-05-20
00810158219816PRINCETON47471-042026-05-20
00810158219748PRINCETON45350-702026-05-19
00810158219755PRINCETON34533-172026-05-19
00810158219625PRINCETON25407-122026-04-22
00810158219687PRINCETON45706-352026-04-22
00810158219694PRINCETON45766-352026-04-22
00810158219700PRINCETON45766-402026-04-22
00810158219717PRINCETON45766-452026-04-22
00810158219724PRINCETON45766-502026-04-22
00810158219731PRINCETON75600-132026-04-22
00810158214538PRINCETON43602-032026-04-21
00810158219465PRINCETON11304-172026-04-21
00810158219472PRINCETON61025-202026-04-21
00810158219489PRINCETON61037-202026-04-21
00810158219496PRINCETON47223-022026-04-21

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
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488153Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488139Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
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10649111062698Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-11
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