AccessGUDID - DEVICE: Disposable Blade Assembly (10861994000288)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Blade Assembly
Version or Model: CTR-455
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CTR-455
Company Name: Hand Biomechanics Lab Inc

Primary DI Number: 10861994000288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 620754127 *Terms of Use

Device Description: Endoscopic Carpal Tunnel Release Disposable Blade Assembly

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?
58783	Hand ligament surgical release instrument	A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222490	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: d0d2f3a3-5560-49ee-aab8-cf3fcb166368
Public Version Date: October 04, 2023
Public Version Number: 3
DI Record Publish Date: December 06, 2021