AccessGUDID - DEVICE: Arthrex® (00888867286580)

GUDID

Device Identifier (DI) Information

Brand Name: Arthrex®
Version or Model: ABS-10080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABS-10080
Company Name: ARTHREX, INC.

Primary DI Number: 00888867286580
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131747628 *Terms of Use

Device Description: Thrombinator™ System

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:	No
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?
47155	Haematological concentrate system preparation kit, thrombin separation	A collection of sterile devices intended for use at the point-of-care for preparation of autologous thrombin (AT) from a blood specimen. The kit components, with the blood specimen, are directly placed in a dedicated centrifuge that separates the AT from the peripheral blood. The AT preparations, in combination with autologous plasma and concentrated platelets, can be applied to surgical wounds to help control minor bleeding, or mixed with bone graft materials to assist the healing and/or graft acceptance process. The kit may include sample drawing devices. 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: 76a9f834-fabd-45ed-9857-9d4814cd8fe3
Public Version Date: March 11, 2020
Public Version Number: 5
DI Record Publish Date: September 30, 2018

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
No Secondary DIs found

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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