AccessGUDID - DEVICE: NA (06009544011057)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: IE4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SOUTHERN IMPLANTS (PTY) LTD

Primary DI Number: 06009544011057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 636239584 *Terms of Use

Device Description: Ext. Hex Cylindrical Implant, Ultra-Short, Ø3.75 x 4mm

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?
63290	Facial prosthesis attachment implant	A sterile implantable device intended to be used to attach an externally-applied facial reconstruction prosthesis to a facial bone(s). It is typically in the form of a small metallic screw, implanted into an appropriate facial bone(s), with a proximal connection point for attachment of the prosthesis after full osteointegration of the implant has occurred.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZE	Prosthesis, Nose, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161548	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: 1d652abf-4d4c-4367-a447-4bc0cbe265b9
Public Version Date: September 14, 2022
Public Version Number: 2
DI Record Publish Date: January 15, 2019

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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