AccessGUDID - DEVICE: PRINCETON (00810158215108)

GUDID

Device Identifier (DI) Information

Brand Name: PRINCETON
Version or Model: 33694-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Princeton Medical Group, Inc.

Primary DI Number: 00810158215108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012857277 *Terms of Use

Device Description: MALLET ONE INTERGHANGEABLE PLASTIC DISC (ONE SIDE STEELE 25MMØ 230G (.50LBS) ALUMINIUM HANDLE 7.25"

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:	No
Prescription Use (Rx):	No
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?
11950	Percussion hammer, manual, reusable	A hand-held manual instrument designed to be used by an examining physician to gently tap near a patient's joints to test reflexes (e.g., patellar, ankle reflexes). It consists of a handle and shaft typically made of stainless steel, and has a head that may be ring, wedge, or dome shaped and is made of a soft material (e.g., rubber or plastic). Some devices may be fitted with a spike, brush, or other detachable component at the proximal end that can be used for neurological examinations. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXL	Mallet

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: dbb79d25-8d2d-445f-ac03-9d52c717e862
Public Version Date: May 22, 2025
Public Version Number: 1
DI Record Publish Date: May 14, 2025