AccessGUDID - DEVICE: simply RePlant® Implant (10841307108313)

GUDID

Device Identifier (DI) Information

Brand Name: simply RePlant® Implant
Version or Model: 604313U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 604313U
Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC

Primary DI Number: 10841307108313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868856969 *Terms of Use

Device Description: Ø4.3 x 13 Platform 4.3mmD

Device Characteristics

What MRI safety information does the labeling contain?	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):	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:	Yes
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?
55847	Dental implant system	A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061319	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
Device Size Text, specify: 4.3mmD x 13mmL

Device Record Status

Public Device Record Key: e4ad5ffe-6089-427f-a0ae-b3e5ddb1f5c7
Public Version Date: December 19, 2024
Public Version Number: 4
DI Record Publish Date: September 14, 2015