FDA.reportPublic FDA data

Bone Marrow Harvest Needle

Primary DI
20886333007664
Brand
Bone Marrow Harvest Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
BMHN1104VX
Catalog number
BMHN1104VX
Device description
Bone Marrow Harvest Needle 11ga x 4in
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333007664PackageGS110In Commercial Distribution
00886333007660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300766420886333007664
00886333007660008863330076608863330076600886333007660

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20886333227864V-Stick Vascular Access Set391504300E391504300E2026-03-20
20886333227871V-Stick Vascular Access Set391505300E391505300E2026-03-20
20886333227888V-Stick Vascular Access Set 391505400E391505400E2026-03-20
20886333227895V-Stick Vascular Access Set391604300E391604300E2026-03-20
20886333227901V-Stick Vascular Access Set 391605300E391605300E2026-03-20
20886333227918V- Stick Vascular Access Set391605400E391605400E2026-03-20
20886333227925V-Stick Vascular Access Set391504400E391504400E2026-03-20
20886333227932V-Stick Vascular Access Set391604400E391604400E2026-03-20
20886333209259Tumescent Infiltration Kit1981431981432025-05-02
10886333227584OneStic Micro-Access Introducer4978864978862025-05-02
20886333227116Bone Access NeedleDBANJ0806TLDBANJ0806TL2023-01-03
20886333227659Transfermoral Transcaval Liver Biopsy SystemTF-18CTF-18C2024-08-12
20886333227499ClosureFast GuidewireGW-025-260-1.5JGW-025-260-1.5J2024-07-29
20886333227505ClosureFast GuidewireGW-035-45GW-035-452024-07-29
20886333227512ClosureFast Introducer Sheath IS-7F07IS-7F072024-07-29
20886333227529ClosureFast Introducer Sheath IS-7F11IS-7F112024-07-29
20886333227550ClosureFast Micro Puncture MPK-4FMPK-4F2024-07-29
20886333227567ClosureFast Micro PunctureMPK-5FMPK-5F2024-07-29
20886333227574ClosureFast Tumescent Infiltration KitTIK-01TIK-012024-07-29
20886333227444ClosureFast Arterial NeedleAN-19GEAN-19GE2024-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095210CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095227CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095067CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-25
00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102281Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102458Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102489Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102632Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00801741234187EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-09
10801741234153EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
10801741234160EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741236167EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741234194EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234248EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234262EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741235221EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
10801741234092EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234139EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
00801741234200EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234115EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234146EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234177EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10850075308016HYDRACELL-ORTHO-5RANFAC CORP.KNW2025-09-25
10850075308030HYDRACELL-ORTHO-10RANFAC CORP.KNW2025-09-25
10850075308047HYDRACELL-EXT-5RANFAC CORP.KNW2025-09-25
10850075308061HYDRACELL-EXT-10RANFAC CORP.KNW2025-09-25
08058983746639TRAP EASYH.S. HOSPITAL SERVICE SPAKNW2025-09-23
10810563022725OmniBone Bone Biopsy Kit with 11 Gauge 68mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18
10810563022732OmniBone Bone Biopsy Kit with 11 Gauge 108mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18