AccessGUDID - DEVICE: Surgical Screwdriver (SD 2) (09008737522605)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Screwdriver (SD 2)
Version or Model: 52260
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737522605
Issuing Agency: GS1
Commercial Distribution End Date: February 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Single-Use Surgical Tool

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?
58776	Surgical screwdriver, single-use	A non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFO	Active Implantable Bone Conduction Hearing System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: The product must be stored in its sterile packaging in a dry place
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 52b52190-1f01-475b-83b8-565100700ad7
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: October 27, 2019