FDA.report

Osty-Core™ Bone Biopsy Needle

Primary DI
20886333003185
Brand
Osty-Core™ Bone Biopsy Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
OBN16125
Catalog number
OBN16125
Device description
Osty-Core™ Bone Biopsy Needle 16ga x 12.5cm
Published
2016-09-16
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

Related Records

Product Codes

CodeName
KNWInstrument, Biopsy

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886333003185PackageGS110In Commercial Distribution
00886333003181PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep dry and away from sunlight

Sterilization Methods

Method

Contacts

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

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