AccessGUDID - DEVICE: NA (04546540185020)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0215031000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0215-031-000
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540185020
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Round Silicone Wound Drain with Trocar

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?
47977	Whole-blood-recovery autotransfusion system, powered	An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

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: 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
Device Size Text, specify: Diameter: 0.1875 Inch

Device Record Status

Public Device Record Key: 445e197d-69e6-465e-8332-9d094b3d9841
Public Version Date: February 19, 2020
Public Version Number: 2
DI Record Publish Date: September 24, 2018