AccessGUDID - DEVICE: Celling ART PRP System (00817771028887)

GUDID

Device Identifier (DI) Information

Brand Name: Celling ART PRP System
Version or Model: 1601-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Duplicate See 000817771029174
Company Name: Celling Biosciences

Primary DI Number: 00817771028887
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 021560394 *Terms of Use

Device Description: ART PRP 2-Step - this is a duplicate. see 1601-0001 - UDI# 00817771029174

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?
46923	Haematological concentrate system preparation kit, platelet concentration	A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. 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 [?]
BK150221	0

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: 36e68611-7eae-4587-a1d2-f9ee6fab90d1
Public Version Date: April 14, 2025
Public Version Number: 6
DI Record Publish Date: March 14, 2019