AccessGUDID - DEVICE: Integra OS™ (10381780112082)

GUDID

Device Identifier (DI) Information

Brand Name: Integra OS™
Version or Model: IOS10155
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IOS10155
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780112082
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Integra OS™ Osteoconductive Scaffold - 5cc Putty

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":	Yes
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
Handling Environment Temperature: between 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 cc

Device Record Status

Public Device Record Key: c5e8c3ca-17f6-4eb3-ac6d-438ad3d3641d
Public Version Date: August 15, 2023
Public Version Number: 8
DI Record Publish Date: September 23, 2015