Duns Number:015272206
Device Description: Pearce spatula, angled, packaged individually, sterile, disposable, box of 3 * * SPECIAL O Pearce spatula, angled, packaged individually, sterile, disposable, box of 3 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 10 BOXES AND 4-6 WEEK LEAD TIME * *
Catalog Number
195141
Brand Name
Ambler Surgical
Version/Model Number
Pearce spatula
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HND
Product Code Name
Spatula, ophthalmic
Public Device Record Key
08f74284-2a81-4866-bf6c-cd2ce2291002
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
January 07, 2021
Package DI Number
00190660199401
Quantity per Package
5
Contains DI Package
10190660199408
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |