AccessGUDID - DEVICE: PENTAX Medical (04961333254620)

GUDID

Device Identifier (DI) Information

Brand Name: PENTAX Medical
Version or Model: OE-B17
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOYA CORPORATION

Primary DI Number: 04961333254620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691519705 *Terms of Use

Device Description: PENTAX Medical R/L Assistant Knob OE-B17

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):	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?
64376	Device control handling knob	A hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope And Accessories, Flexible/Rigid
FDS	Gastroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241213	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
High-level Disinfectant
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: faf58b8b-3acf-484e-a679-c3d5e4efa776
Public Version Date: December 23, 2024
Public Version Number: 1
DI Record Publish Date: December 13, 2024

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

Customer Contact

[?]

No Customer Contact currently defined

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