AccessGUDID - DEVICE: PERCUVANCE (14026704582928)

GUDID

Device Identifier (DI) Information

Brand Name: PERCUVANCE
Version or Model: IPN027881
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PCVSHL3
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704582928
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: 2.9MM PERCUTANEOUS SHAFT 36CM

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?
47829	Surgical instrument handle, non-torque-limiting	A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153063	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
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Storage Environment Temperature: between 16 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 1.3 Inch
Length: 15.8 Inch

Device Record Status

Public Device Record Key: a021def5-08e2-4530-9c97-87e36380ccd3
Public Version Date: June 16, 2021
Public Version Number: 8
DI Record Publish Date: November 16, 2017