FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158210158
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
75430-13
Device description
"EXCAVATOR WITH HOLE DOUBLE ENDED 1.5MM / 2.5MM 5.75"""
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FHLScoop

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158210158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158210158008101582101588101582101580810158210158

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810238290001PRINCETON09525-222026-09-22
00810238290018PRINCETON41085-202026-09-22
00810238290025PRINCETON33711-202026-09-22
00810238290049PRINCETON19128-182026-09-22
00810238290063PRINCETON13221-182026-09-22
00810238290070PRINCETON33476-982026-09-22
00810238290087PRINCETON11187-122026-09-22
00810238290094PRINCETON45010-302026-09-22
00810238290100PRINCETON45010-452026-09-22
00810238290117PRINCETON45010-552026-09-22
00810238290124PRINCETON45010-652026-09-22
00850088713756PRINCETON33707-172026-09-22
00850088713763PRINCETON33474-972026-09-22
00850088713770PRINCETON41250-152026-09-22
00850088713787PRINCETON41297-102026-09-22
00850088713824PRINCETON19234-202026-09-22
00850088713862PRINCETON19803-162026-09-22
00850088713886PRINCETON33950-012026-09-22
00850088713893PRINCETON03340-502026-09-22
00850088713916PRINCETON11110-112026-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B382SD9162111090Surgical DirectSurgical Direct, Inc.FHL2026-07-28
04049047109723GimmiGimmi GmbHFHL2025-05-27
04049047109747GimmiGimmi GmbHFHL2025-05-27
04049047109778GimmiGimmi GmbHFHL2025-05-27
04049047109785GimmiGimmi GmbHFHL2025-05-27
04049047109792GimmiGimmi GmbHFHL2025-05-27
04049047109808GimmiGimmi GmbHFHL2025-05-27
08403207009654Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009661Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009678Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009685Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
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00840343721763GEN2SURGIX MEDICAL LLCFHL2024-04-05
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