AccessGUDID - DEVICE: OURY-GUYE & FILS (03665624005076)

GUDID

Device Identifier (DI) Information

Brand Name: OURY-GUYE & FILS
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZD1340M
Company Name: ETABLISSEMENTS OURY GUYE ET FILS

Primary DI Number: 03665624005076
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 281906511 *Terms of Use

Device Description: MEDIUM LAMBOTTE HOOK

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?
33542	Bone hook	A hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08c5084e-29b6-41e9-92a4-cdb0df5772a4
Public Version Date: April 14, 2022
Public Version Number: 1
DI Record Publish Date: April 06, 2022