AccessGUDID - DEVICE: Integra OS® (10381780071150)

GUDID

Device Identifier (DI) Information

Brand Name: Integra OS®
Version or Model: IOSMM030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IOSMM030
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780071150
Issuing Agency: GS1
Commercial Distribution End Date: August 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: The Integra OS Osteoconductive Scaffold - Moldable Morsels are a resorbable bone void filler made from a porous highly purified microfibrillar collagen combined with high purity tricalcium phosphate (TCP) granules and cubes. The implant is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. It quickly imbibes fluids, making it easy to combine with bone marrow aspirate.

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?
47967	Bone matrix implant, composite	A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
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
Special Storage Condition, Specify: Store at room temperature. Avoid excessive heat or humidy. Do not refrigerate.
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3cc

Device Record Status

Public Device Record Key: 08ccb69c-37e7-4cc9-91de-de485955e908
Public Version Date: August 22, 2023
Public Version Number: 6
DI Record Publish Date: September 22, 2015