AccessGUDID - DEVICE: Medtronic Resuable Instruments (00643169618374)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic Resuable Instruments
Version or Model: EX0315002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169618374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: BLADE EX0315002 SICKLE

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?
44987	Manual surgical saw, flexible	A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTS	KNIFE, ORTHOPEDIC

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: 2337758c-d2ba-43d1-983c-2a98c68d4fbc
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 11, 2022