AccessGUDID - DEVICE: Arthrex® (00888867266346)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: ABS-10062CDN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABS-10062CDN
Company Name: ARTHREX, INC.

Primary DI Number: 00888867266346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: Angel System with Powered Aspiration Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45815	Haemodialysis citrate anticoagulation solution	A citric acid (citrate) formulation introduced into the extracorporeal circuit of a dialysis system to inhibit the coagulation of blood, typically during continuous renal replacement therapy (CRRT) - physiological dialysis performed over a 24-hour period or longer. Citrate inhibits coagulation by binding with calcium and rendering calcium unavailable to the clotting cascade. When blood from the extracorporeal circuit is returned to the patient it mixes with central venous blood which contains calcium that has been continuously administered to the patient, and the anticoagulant effect is neutralized. It is typically supplied in a polyvinyl chloride (PVC) bag. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet and plasma separator for bone graft handling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5728b22f-4458-424f-bfd7-5d942d93167a
Public Version Date: July 23, 2020
Public Version Number: 9
DI Record Publish Date: November 28, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M150ABS10062CDN1

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)934-4404
Email: complaints@arthrex.com

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