Primary Device ID | B033K216 |
NIH Device Record Key | c4a92355-6f6e-480e-83e8-b63c6ad0731c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rosenkranz Pediatric Open Heart Retractor |
Version Model Number | K-216 |
Catalog Number | K-216 |
Company DUNS | 004171112 |
Company Name | Kapp Surgical Instrument Co. |
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 | false |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B033K216 [Primary] |
GAD | Retractor |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B033K216]
Moist Heat or Steam Sterilization
[B033K216]
Moist Heat or Steam Sterilization
[B033K216]
Moist Heat or Steam Sterilization
[B033K216]
Moist Heat or Steam Sterilization
[B033K216]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-05-26 |
Device Publish Date | 2022-05-18 |
B033K217 | Pediatric malleable blade. |
B033K216 | Child Malleable Blade |