SUMMIT MEDICAL 3003
GUDID 00810061911937
ACCUFLO, STERILE, X-LARGE
KRISHNA IMPORTS INC
Lacrimal punctum plug| Primary Device ID | 00810061911937 |
| NIH Device Record Key | 10d3c428-339a-44e0-9c6f-63e870da0e54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUMMIT MEDICAL |
| Version Model Number | 3003 |
| Catalog Number | 3003 |
| Company DUNS | 081853285 |
| Company Name | KRISHNA IMPORTS INC |
| Device Count | 2 |
| DM Exempt | true |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com | |
| Phone | 8592594925 |
| info@stephensinst.com |
Device Dimensions
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
| Outer Diameter | 1.02 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810061911265 [Primary] |
| GS1 | 00810061911937 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140352
FDA Product Code
| LZU | Plug, Punctum |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
[00810061911937]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-22 |
| Device Publish Date | 2024-01-12 |
On-Brand Devices [SUMMIT MEDICAL]
| 00810061911937 | ACCUFLO, STERILE, X-LARGE |
| 00810061911920 | ACCUFLO, STERILE, LARGE |
| 00810061911913 | ACCUFLO, STERILE, MEDIUM |
| 00810061911982 | ACCUFLO, STERILE, SMALL |
| 00810061911975 | COMFORT TIP, STERILE, LARGE |
| 00810061911968 | COMFORT TIP, STERILE, MEDIUM |
| 00810061911951 | COMFORT TIP, STERILE, SMALL |
| 00810061911944 | COMFORT TIP, STERILE, X-SMALL |
Trademark Results [SUMMIT MEDICAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUMMIT MEDICAL 76311856 3043090 Live/Registered |
SUMMIT MEDICAL LIMITED 2001-09-12 |
 SUMMIT MEDICAL 74676630 2038183 Dead/Cancelled |
Summit Medical Systems, Inc. 1995-05-16 |
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