AccessGUDID - DEVICE: DuaFit® (03701337603014)

GUDID

Device Identifier (DI) Information

Brand Name: DuaFit®
Version or Model: A60 SP002 B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: IN2BONES

Primary DI Number: 03701337603014
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 263616749 *Terms of Use

Device Description: Interphalangeal 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?
33697	Proximal interphalangeal joint prosthesis, one-piece	A sterile implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132912	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
Length: 14 Millimeter
Angle: 0 degree

Device Record Status

Public Device Record Key: aee11a7e-ef83-494f-82cf-2ba0f57c1ef8
Public Version Date: December 24, 2024
Public Version Number: 3
DI Record Publish Date: November 04, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +33472292626
Email: contact@in2bones.com

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