AccessGUDID - DEVICE: Insight (00817517026900)

GUDID

Device Identifier (DI) Information

Brand Name: Insight
Version or Model: 138017
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 138017
Company Name: MARKETLAB INC.

Primary DI Number: 00817517026900
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 848917027 *Terms of Use

Device Description: Insight GynoCart with Exam Light

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:	Yes
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?
36614	Examination/operating table component trolley	A dedicated cart designed as a framework on wheels intended to transport a component/accessory of an examination and/or operating table (e.g., patient supports, stirrups, tabletops) within a hospital/institution department or ward. It may include baskets, shelves, hooks and/or organizers for storing and/or transporting components. This trolley (cart) may be used in association with an examination/operating table and may have a fixed height or be hydraulically height-adjustable by a pump (e.g., to position a tabletop onto or off a column). It is not intended to be used to perform procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGX	Table, Examination, Medical, Powered

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: 5362933f-a378-4806-a3a1-f1a28d23520d
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: September 08, 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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