| Primary Device ID | 00840199517114 |
| NIH Device Record Key | a57271a2-33ad-489c-8c74-38cd67a37068 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lamina Spreader |
| Version Model Number | 7340-11 |
| Catalog Number | 7340-11 |
| Company DUNS | 007928633 |
| Company Name | KOROS U.S.A., INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840199517114 [Direct Marking] |
| GS1 | 10840199517111 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
[00840199517114]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-11 |
| Device Publish Date | 2021-10-01 |
| 00840199517404 | Lumbar Lamina Spreader 3 Pronged Tip, 120mm Arm Length |
| 00840199517381 | Lumbar Lamina Spreader 2 Pronged Tip, 120mm Arm Length |
| 00840199517374 | Lumbar Lamina Spreader 1 Pronged Tip, 120mm Arm Length |
| 00840199517367 | Lumbar Lamina Spreader 1 Pronged Tip, 75mm Arm Length |
| 00840199517329 | PLIF Angled Lamina Spreader w/6 Teeth 16mm Wide, 12"/31cm Overall Length, 12.5cm Deep |
| 00840199517312 | PLIF Angled Lamina Spreader w/4 Teeth 10mm Wide, 12.5cm Deep, 12"/31cm Overall Length |
| 00840199517305 | Lumbar Anterior Lamina Spreader, 20mm Offset Tip, 28cm Long, 7.5cm Deep |
| 00840199517299 | Anterior Lamina Spreader 28cm, 7.5cm Deep |
| 00840199517282 | Anterior Lamina Spreader Serrated 28cm |
| 00840199517145 | Cervical Lamina Spreader 7cm Deep 4mm Tip |
| 00840199517138 | Cervical Lamina Spreader 7cm Deep 3mm Tip |
| 00840199517121 | Delicate Cervical Lamina Spreader 2.5mm Wide Tip, 7cm Deep |
| 00840199517114 | Cervical Lamina Spreader 3mm Tip 16cm Total Length |
| 00840199517107 | Cervical Lamina Spreader 4mm Tip 16cm Total Length |
| 00840199517169 | Cervical Lamina Spreader 9.5cm Deep 4mm Tip |
| 00840199517152 | Cervical Lamina Spreader 9.5cm Deep 3mm Tip |
| 00840199517398 | Lumbar Laminar Spreader 3 Prg, 102mm arm length |
| 00840199517275 | Angled Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep |
| 00840199517268 | Laminia Spread 16mm,7.5cm dp |
| 00840199517251 | Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep |