Primary Device ID | 04056481145941 |
NIH Device Record Key | 7a5ef19e-ea20-4a6c-a213-032b855c8660 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Disposable Loop-X Source Drape (1 Pc) |
Version Model Number | 22183-12 |
Company DUNS | 314482980 |
Company Name | Brainlab AG |
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 | 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04056481145941 [Package] Contains: 04056481146009 Package: [5 Units] In Commercial Distribution |
GS1 | 04056481146009 [Primary] |
PUI | Drape, Surgical, Exempt |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-04 |
Device Publish Date | 2025-07-25 |
04056481145941 - Disposable Loop-X Source Drape (1 Pc) | 2025-08-04The source drape is intended to sterile cover the source (cone beam) of the Loop-X. |
04056481145941 - Disposable Loop-X Source Drape (1 Pc) | 2025-08-04 The source drape is intended to sterile cover the source (cone beam) of the Loop-X. |
04056481145330 - CRANIAL 4PI HEADREST PLATFORM | 2025-07-04 |
04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD | 2025-07-04 |
04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.) | 2025-07-04 |
04056481145361 - CRANIAL 4PI WEDGE 10 DEG. | 2025-07-04 |
04056481145378 - CRANIAL 4PI SPACER 20MM | 2025-07-04 |
04056481145453 - CRANIAL 4PI INDEXING PLATE | 2025-07-04 |
04056481145460 - CRANIAL 4PI HEAD SUPPORT WIDE | 2025-07-04 |