epic edge
GUDID 00855019008031
10/0 BL Mono Nylon, 30 cm length, 3/8 cir Spatula Ndl, Double Arm (single device)
R.K. MANUFACTURING CORPORATION OF CONNECTICUT
Nylon suture, non-bioabsorbable, monofilament| Primary Device ID | 00855019008031 |
| NIH Device Record Key | 344c4983-e757-4ef3-b9f3-ed139632a363 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | epic edge |
| Version Model Number | N2627 |
| Company DUNS | 116162108 |
| Company Name | R.K. MANUFACTURING CORPORATION OF CONNECTICUT |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com | |
| Phone | 203-797-8700 |
| alabarre@rkmcorp.com |
Device Dimensions
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
| Length | 30 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 73 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855019008031 [Primary] |
| GS1 | 10855019008038 [Package] Package: Box [12 Units] In Commercial Distribution |
FDA Product Code
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
[00855019008031]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-06-13 |
On-Brand Devices [epic edge]
| 00855019008031 | 10/0 BL Mono Nylon, 30 cm length, 3/8 cir Spatula Ndl, Double Arm (single device) |
| 00855019008024 | 10/0 BL Mono Nylon, 30 cm length, 1/2 cir Spatula Ndl, Double Arm (single device) |
| 00855019008017 | 10/0 BL Mono Nylon, 10 cm length, 3/8 cir Spatula Ndl, Single Arm (single device) |
| 00855019008000 | 10/0 BL Mono Nylon, 10 cm length, 1/2 cir Spatula Ndl, Single Arm (single device) |
Trademark Results [epic edge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIC EDGE 87129070 5330805 Live/Registered |
TransAct Technologies Incorporated 2016-08-05 |
 EPIC EDGE 87126293 5137648 Live/Registered |
Pacific Coast Building Products, Inc. 2016-08-03 |
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