AccessGUDID - DEVICE: OsteoExpress (90815634020903)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoExpress
Version or Model: GDNS-5215
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Micromedics, Inc.

Primary DI Number: 90815634020903
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 066839630 *Terms of Use

Device Description: Graft Delivery Device, 15 cc, Bulk, Non Sterile, Vented. Quantity is Maximum 25 as customer orders

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):	No
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?
46119	Bone graft delivery kit	A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151543	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 3f64e268-c0d5-4fe8-ae20-0608e7ad27bf
Public Version Date: June 23, 2025
Public Version Number: 4
DI Record Publish Date: March 21, 2019