AccessGUDID - DEVICE: INTENSA (M368744COM1)

GUDID

Device Identifier (DI) Information

Brand Name: INTENSA
Version or Model: 744-COM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M368744COM1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132016168 *Terms of Use

Device Description: HYDRAULIC SURGICAL STOOL

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?
32307	Operating room stool, manually-adjusted	A manually-operated seat intended to be occupied by a surgeon or operating room (OR) staff [e.g., surgical nurses, surgical assistants, anaesthetists] during surgical procedures as an alternative to standing. It may provide the occupier with support for the back or arms. It is typically designed with at least one manually-operated ergonomic adjustment (e.g., height and position adjustments), which is typically adjusted by a hand or foot lever, and may features wheels (castors) and breaks.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZM	Stool, Operating-Room

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: 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: 663a3d88-f03e-422b-8dce-ec2b0a9354d1
Public Version Date: December 25, 2025
Public Version Number: 3
DI Record Publish Date: November 15, 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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 7703684700
Email: cs@grahamfield.com

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