AccessGUDID - DEVICE: Dr.Paleys Osteotomy System (07540194010551)

GUDID

Device Identifier (DI) Information

Brand Name: Dr.Paleys Osteotomy System
Version or Model: DRPF-601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DRPF-601
Company Name: Orthopediatrics Canada ULC

Primary DI Number: 07540194010551
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243298854 *Terms of Use

Device Description: Dr PALEY FASCIOTOME

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):	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?
35141	Scalpel, reusable	A hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cfaa6d00-0849-4acc-8c94-8d7bbf97e4e5
Public Version Date: May 13, 2025
Public Version Number: 3
DI Record Publish Date: August 12, 2020