DEVICE: NA (00840085272301)

Device Identifier (DI) Information

NA
JBAC00025
In Commercial Distribution
JBAC00025
HYHTE HOLDINGS, INC.
00840085272301
GS1

1
073029645 *Terms of Use
AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 2.5 CC
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
Yes

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60504 Vertebral bone filler, bioabsorbable
A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device is typically a sterile powder made of a calcium compound (e.g., calcium phosphate, calcium carbonate, hydroxyapatite), that is mixed with its sterile diluent prior to implantation, and designed to be implanted during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MQV Filler, Bone Void, Calcium Compound
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

96311c1b-8c4a-49e3-a18c-083a241154a8
January 17, 2024
1
January 09, 2024
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
Yes CLOSE

Customer Contact

[?]
4695015530
parker@asturamedical.com
CLOSE