AccessGUDID - DEVICE: N/A (06009544049579)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: MSC-SP4510
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SOUTHERN IMPLANTS (PTY) LTD

Primary DI Number: 06009544049579
Issuing Agency: GS1
Commercial Distribution End Date: November 22, 2099
Device Count: 1
Labeler D-U-N-S® Number*: 636239584 *Terms of Use

Device Description: Implant MSC SP1 Ø4.5x10mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55859	White blood cell count IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232418	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8937ba57-bee4-4219-a361-87f4cfd2e584
Public Version Date: December 05, 2024
Public Version Number: 1
DI Record Publish Date: November 27, 2024