OSSIOfiber® Suture Anchor OF1034754S
GUDID 07290017630632
OSSIOfiber® Suture Anchor 4.75 mm with Black Tape, Blue/White #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 2mm Suture Tape, 1 Blue/White Round #2 Suture.
OSSIO LTD
Tendon/ligament bone anchor, bioabsorbable| Primary Device ID | 07290017630632 |
| NIH Device Record Key | ab10b6a9-8493-4ad0-9d3a-23add024653a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIOfiber® Suture Anchor |
| Version Model Number | OF1034754S |
| Catalog Number | OF1034754S |
| Company DUNS | 600505107 |
| Company Name | OSSIO LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io |
Device Dimensions
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
| Outer Diameter | 4.75 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017630632 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213415
FDA Product Code
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-14 |
| Device Publish Date | 2022-06-06 |
On-Brand Devices [OSSIOfiber® Suture Anchor]
| 07290017630649 | OSSIOfiber® Suture Anchor 4.75 mm Blue/Black Tape, Blue #2 Suture. Package contains: 1 Implant, |
| 07290017630632 | OSSIOfiber® Suture Anchor 4.75 mm with Black Tape, Blue/White #2 Suture. Package contains: 1 Im |
| 07290017630625 | OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black/White Tape, Blue #2 Suture. Package conta |
| 07290017630618 | OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Package con |
| 07290017630601 | OSSIOfiber® Suture Anchor 4.75 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 |
| 07290017630946 | OSSIOfiber® Suture Anchor 5.5 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 S |
| 07290019361169 | OSSIOfiber® Suture Anchor 2.5 mm, with 1.4 mm White/Blue Suture Tape with Needles. Package cont |
| 07290019361152 | OSSIOfiber® Suture Anchor 2.5 mm, with 1.4 mm Blue Suture Tape with Needles. Package contains: |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
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