FDA.report

Arthrex®

Primary DI
00888867316539
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-10011T
Catalog number
ABS-10011T
Device description
ACP + ACD-A Kit
Published
2020-04-10
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

Related Records

Contact Domains

Product Codes

CodeName
ORGPlatelet and plasma separator for bone graft handling

Product Code Classifications

CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867316539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867316539008888673165398888673165390888867316539

GMDN Terms

TermDefinition
Bone marrow biopsy procedure kitA packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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