AccessGUDID - DEVICE: Hallu®- LOCK (10381780052029)

GUDID

Device Identifier (DI) Information

Brand Name: Hallu®- LOCK
Version or Model: 299080ND
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780052029
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The right plate bender is used to bend the Hallu® Lock C plate in combination with the left plate bender in order to match the degree of dorsal flexion required by the case or by the activity of the patient.

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":	Yes
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?
44795	Manual orthopaedic bender, reusable	A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXW	BENDER

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: 8f5d4375-25f7-4e3a-b980-a302ec86f26a
Public Version Date: February 06, 2023
Public Version Number: 3
DI Record Publish Date: May 26, 2017