AccessGUDID - DEVICE: V. Mueller (10885403417597)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: S-TAKER10T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: STAKER10T
Company Name: STERIS CORPORATION

Primary DI Number: 10885403417597
Issuing Agency: GS1
Commercial Distribution End Date: November 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller Neuro/Spine HUMAN TRIAL INST- NOT FOR SALE CLEANACCESS KERRISON RONGEUR T-COAT MICRO HANDLE 1-5MM BITE, LENG 10 inches, 10MM OPN

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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJG	Neurological tray

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: ab484de0-e34c-44a7-a02e-c8663d4f5f9f
Public Version Date: November 07, 2024
Public Version Number: 6
DI Record Publish Date: December 22, 2017