DEVICE: OUSIA bioSTRIP (00614950007608)
Device Identifier (DI) Information
OUSIA bioSTRIP
OUSTP
In Commercial Distribution
OUSTP
ACE SURGICAL SUPPLY CO., INC.
OUSTP
In Commercial Distribution
OUSTP
ACE SURGICAL SUPPLY CO., INC.
OUSIA bioSTRIP 25MMX75MMX1MM 10/BOX 25/BOX/CA
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
47184 | General oral wound dressing, animal-derived |
A collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYC | Bone grafting material, synthetic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 25 Millimeter |
Length: 75 Millimeter |
Device Record Status
bf31389d-3c12-41a0-b82a-1178510a151f
July 07, 2020
3
October 24, 2015
July 07, 2020
3
October 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 |
---|---|---|---|---|---|
10614950007605 | 25 | 00614950007608 | In Commercial Distribution | Tyvec Bag |
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)588-3100
214
ritaknight@acesurgical.com
ritaknight@acesurgical.com