AccessGUDID - DEVICE: Introducer Sheath (20613994840312)

GUDID

Device Identifier (DI) Information

Brand Name: Introducer Sheath
Version or Model: 3805-012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC PS MEDICAL, INC.

Primary DI Number: 20613994840312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 089055867 *Terms of Use

Device Description: SHEATH 3805-012 PEELAWAY INTRO D12 5PK

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?
32864	Wire/ligature passer, reusable	A hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWG	ENDOSCOPE, NEUROLOGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990333	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f61e4f2b-9068-42b9-9724-e6c8b5a352a1
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: June 13, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00613994840318 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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