DEVICE: DELTA (07613252713111)

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

Device Identifier (DI) Information
DELTA
70-92044
In Commercial Distribution
70-92044
Stryker Leibinger GmbH & Co. KG
07613252713111
GS1

1
316153956 *Terms of Use
Delta 1.7mm Panel 2x21 Ctrsinks x 0.75mm
CLOSE

Device Characteristics
MR Safe
No
No
Yes
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?
46641 Craniofacial fixation plate, bioabsorbable
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HBW FASTENER, PLATE, CRANIOPLASTY
GXR COVER, BURR HOLE
JEY PLATE, BONE
MAI Fastener, fixation, biodegradable, soft tissue
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K213777 000
K993061 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 49 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Thickness: 0.75 Millimeter
Device Size Text, specify: 3D Plates: 2x21 Holes
CLOSE

Device Record Status
16dad63c-c41d-497a-963b-4ef1c460fab7
September 18, 2023
9
September 24, 2015
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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE