AccessGUDID - DEVICE: Actifuse Microgranules (05060050780456)

GUDID

Device Identifier (DI) Information

Brand Name: Actifuse Microgranules
Version or Model: 506005078045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 506005078045
Company Name: Apatech Ltd

Primary DI Number: 05060050780456
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221517829 *Terms of Use

Device Description: Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 5ml pack size

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?
17751	Bone matrix implant, synthetic, non-antimicrobial	A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone grafting material, synthetic
MQV	FILLER, BONE VOID, CALCIUM COMPOUND

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
Storage Environment Temperature: between 15 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 7fedaaa8-2a20-46a3-bdca-24f5a6b14a52
Public Version Date: July 27, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2015

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)933-0303
Email: Medinfo_medproducts@baxter.com

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