AccessGUDID - DEVICE: EXPert Nail (10886982087614)

GUDID

Device Identifier (DI) Information

Brand Name: EXPert Nail
Version or Model: 04.013.316S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04013316S
Company Name: Synthes GmbH

Primary DI Number: 10886982087614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: 9MM TI CANNULATED RETROGRADE FEMORAL NAIL-EX/180MM-STERILE

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?
33187	Femur intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.e., not dedicated to arthrodesis/joint fusion). It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033618	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 1718b31b-9a8a-4560-a8a4-13094c395711
Public Version Date: February 06, 2025
Public Version Number: 6
DI Record Publish Date: September 14, 2015

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
HIBCC	H67904013316S0

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

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

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