| Primary Device ID | M991IK312212 |
| NIH Device Record Key | 137b7030-ec15-47b2-9cca-ba576b225d96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standard Introducer |
| Version Model Number | Straight Wing Tearaway |
| Catalog Number | IK31221 |
| Company DUNS | 013861471 |
| Company Name | NORFOLK MEDICAL |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com | |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M991IK312211 [Primary] |
| HIBCC | M991IK312212 [Package] Contains: M991IK312211 Package: Box [2 Units] In Commercial Distribution |
| DYB | INTRODUCER, CATHETER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
[M991IK312212]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2015-09-01 |
| M991IK712212 | 10F Standard Introducer Kit |
| M991IK512212 | 8F Standard Introducer Kit |
| M991IK312212 | 6F Standard Introducer Kit |