Duns Number:257382580
Device Description: The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come i The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various applications. The same basic piece is available modified in design to shield different parts of the body. You can shield eyelashes, eyebrows, eyelids, freckles, lips, gums, teeth, etc. and any tissue (deep or superficial) needing protection. Useful during skin resurfacing, incisional procedures, skin depigmentation, etc. In surgery, they can serve as an instrument for retracting tissue and as a backstop. You will discover many uses for it. The bent model is easier to pick up when gloved.
Catalog Number
-
Brand Name
Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare)
Version/Model Number
21-276
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
1a3deb4b-1163-48cb-acb8-83bede3b26f8
Public Version Date
November 29, 2019
Public Version Number
1
DI Record Publish Date
November 21, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |