FDA.reportPublic FDA data

Lee Medical

Primary DI
00850048404083
Brand
Lee Medical
Company
Tarca LLC
Model
TP-117
Catalog number
TP-117
Device description
Adult Obese LEE ® Bone Marrow Harvest Needle 11 Gauge – 7 inch (176 mm)
Published
2022-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048404083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048404083008500484040838500484040830850048404083

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

Regulatory Flags#

DUNS number
079211808
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048404007Lee MedicalA-152A-1522022-12-20
00850048404014Lee MedicalA-154A-1542022-12-20
00850048404021Lee MedicalB-114B-1142022-12-20
00850048404038Lee MedicalB-115B-1152022-12-20
00850048404045Lee MedicalB-133B-1332022-12-20
00850048404052Lee Medical TP-114TP-1142022-12-20
00850048404069Lee MedicalTP-115TP-1152022-12-20
00850048404076Lee MedicalTP-133TP-1332022-12-20
00850048404090Bone Shark®BS-101BS-1012022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
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00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
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00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
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00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26
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05060212051738Clamp Cover White (Med) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051745Clamp Cover Blue (Large) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
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