AccessGUDID - DEVICE: THREAD FORMER M.2 (D7700395083)

GUDID

Device Identifier (DI) Information

Brand Name: THREAD FORMER M.2
Version or Model: MF-425/500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MF-425/500
Company Name: SWEDEN & MARTINA SPA

Primary DI Number: D7700395083
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 433815198 *Terms of Use

Device Description: THREAD FORMER M.2 INTERNAL IMPLANTS

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:	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?
64528	Dental implant internal thread shaping tool	A cylindrical rod with a spiralled cutting distal end, similar to a drill bit or a screw, intended to be used to shape and rectify the internal thread of a dental implant that has been implanted into bone. It is made of metal and is designed to be attached to a manual screwdriver. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 3debdcac-82b9-4a91-a6f3-cfcf368b8913
Public Version Date: July 18, 2023
Public Version Number: 1
DI Record Publish Date: July 10, 2023

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 844.862.7846
Email: info.us@sweden-martina.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES