AccessGUDID - DEVICE: SpineSmith Fusionary Graft Delivery System (00817771027316)

GUDID

Device Identifier (DI) Information

Brand Name: SpineSmith Fusionary Graft Delivery System
Version or Model: 0851-0030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0851-0030
Company Name: Celling Biosciences

Primary DI Number: 00817771027316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021560394 *Terms of Use

Device Description: BMA Kit with 30cc Syringes

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?
43999	Bone graft syringe, single-use	A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston
LWE	Bone Marrow Collection/Transfusion Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK090047	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: a6b260c5-b3ef-4227-afc1-5aba7ad7735b
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: December 29, 2016