FDA.reportPublic FDA data

Custom Bone Marrow Tray

Primary DI
20886333217339
Brand
Custom Bone Marrow Tray
Company
ARGON MEDICAL DEVICES, INC.
Model
CB0181TL
Catalog number
CB0181TL
Device description
Custom Bone Marrow Tray
Published
2022-07-14
Public version status
New
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
OJTAspiration Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJTAspiration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333217339PackageGS15In Commercial Distribution
00886333217335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633321733920886333217339
00886333217335008863332173358863332173350886333217335

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool place and avoid temperature extremes

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
true
HCT/P
false
Kit
true
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
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956496552CARDINAL HEALTHCardinal Health 200, LLCOJT2026-06-08
10198956383265CARDINAL HEALTHCardinal Health 200, LLCOJT2026-04-28
10198956458642CARDINAL HEALTHCardinal Health 200, LLCOJT2026-04-27
10198956408098CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-23
10198956391956CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-19
10198956164017CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
10198956338555CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
10198956387393CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-23
10198956368040CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-13
10198956276017CARDINAL HEALTHCardinal Health 200, LLCOJT2025-12-09
10198956162525CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-19
10198956262782CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-13
10198956240209CARDINAL HEALTHCardinal Health 200, LLCOJT2025-10-23
10198956170087CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-11
10198956163867CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-05
10198956112117CARDINAL HEALTHCardinal Health 200, LLCOJT2025-07-28
10198956110076CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-13
10198956099746CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-10
10198956086517CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-05
10198956015913CARDINAL HEALTHCardinal Health 200, LLCOJT2025-03-31
10197106970621CARDINAL HEALTHCardinal Health 200, LLCOJT2025-02-26
10197106884096CARDINAL HEALTHCardinal Health 200, LLCOJT2025-01-13
10197106848500CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-25
10197106817445CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
10197106821213CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
10197106782309CARDINAL HEALTHCardinal Health 200, LLCOJT2024-10-03
10197106755471CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-30
10197106755099CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-28
10197106723432CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-26
10197106718179CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-16