Primary Device ID | 00724995153182 |
NIH Device Record Key | 59283234-d052-4a7b-a1fa-7a5b3e91ae68 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | rShield |
Catalog Number | LB56 |
Company DUNS | 036985604 |
Company Name | STERIS CORPORATION |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx | |
Phone | +1(800)548-4873 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00724995153182 [Primary] |
KPY | Shield, protective, personnel |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-08 |
Device Publish Date | 2021-03-31 |
00724995152970 - NA | 2021-04-12 The Plastic LightHandle non-sterile is for receiving disposable light handle cover and used with HarmonyAIR and Harmony Surgical |
00724995152987 - NA | 2021-04-12 The Aluminum Sterilizable Handle is a reusable surgical light handle without sterile surgeon control. |
00724995152994 - NA | 2021-04-12 The Surgeon Control Sterilizable Handle provides sterile surgeon control of surgical light intensity, pattern, power and positio |
00724995153007 - NA | 2021-04-12 The Silicone Ring is used with the Sterilizable Aluminum Light Handle. |
00724995156428 - NA | 2021-04-12 The 2-inch TLT Pad - Head Section is used with surgical tables. |
00724995156435 - NA | 2021-04-12 The 2-inch TLT Pad for Back Section is used with surgical tables. |
00724995156442 - NA | 2021-04-12 The 2-inch TLT Table Pads Complete Set is used with the STERIS Cmax, 4085 and 5085 General Surgical Table. |
00724995156459 - NA | 2021-04-12 The 5085 Harmony Standard Headrest with 2-inch PRS Pads is used with the 5085 Harmony Surgical Table. |