AccessGUDID - DEVICE: THUMB TMC LG 16MM (M209142720)

GUDID

Device Identifier (DI) Information

Brand Name: THUMB TMC LG 16MM
Version or Model: 14272
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOPRO, INC.

Primary DI Number: M209142720
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618749857 *Terms of Use

Device Description: No description.

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?
33539	Carpometacarpal interpositional spacer, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into the first carpometacarpal (CMC) joint (i.e., between the trapezium and the first metacarpal bone) to treat pain, instability, and/or motion disabilities of the thumb caused by arthritis. It is typically spherical in shape and made of metal or ceramic.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYI	Prosthesis, Wrist, Carpal Trapezium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964472	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: 4384958f-9e90-4286-9e74-75c6c7701f8b
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: September 16, 2015

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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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