AccessGUDID - DEVICE: Dyna Locking Trochanteric Nail (08800037567369)

GUDID

Device Identifier (DI) Information

Brand Name: Dyna Locking Trochanteric Nail
Version or Model: NG2415
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CG MedTech Co.,Ltd.

Primary DI Number: 08800037567369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688811082 *Terms of Use

Device Description: No description.

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:	Yes
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?
66946	Femoral neck fixation sliding bone screw	A dedicated, partially-threaded rod intended to be implanted through the sleeve of a femoral neck fixation plate/sleeve (not included) and into the neck and head of the femur to treat a trochanteric fracture. It is commonly referred to as a dynamic hip screw or lag screw, however it has no screw head, but instead includes a female thread at the proximal end to accept a compression screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTY	PIN, FIXATION, SMOOTH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: dd28b8ed-610e-4943-8b7c-ec8c5e2b7096
Public Version Date: January 06, 2025
Public Version Number: 5
DI Record Publish Date: May 23, 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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

No Customer Contact currently defined

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