AccessGUDID - DEVICE: gSource (00840314269706)

GUDID

Device Identifier (DI) Information

Brand Name: gSource
Version or Model: gS 87.4070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: gS 87.4070
Company Name: GSOURCE LLC

Primary DI Number: 00840314269706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008162518 *Terms of Use

Device Description: gExtractor, Femoral Head 8 1/2", ZHQC

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?
64297	Femoral head extractor	A surgical instrument designed to help remove the natural femoral head from within the acetabulum during a total hip replacement procedure. It is typically a one-piece instrument with a long slender shaft of various distal-end designs (e.g., screw, fork) intended to be inserted into the femoral neck/head after it has been excised from the femur. Rotational force is provided manually via a handle or by a powered drill/tool. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWB	Extractor

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: 78614e5f-a20d-48b3-8e19-9b01c8c1e4c0
Public Version Date: March 10, 2025
Public Version Number: 1
DI Record Publish Date: February 28, 2025

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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