DEVICE: Darby Dental Supply, LLC (00889813063798)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Darby Dental Supply, LLC
5257012
In Commercial Distribution

DARBY DENTAL SUPPLY, LLC
00889813063798
GS1

1
825137818 *Terms of Use
SPATULA CEMENT 7 DE
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
39610 General-purpose surgical spatula
A hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAF SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
fb449cc9-7547-44e1-9fda-7b71979b9b07
December 09, 2024
1
November 30, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE