AccessGUDID - DEVICE: V. Mueller (70885403135943)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: 300.16SC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 300.16SC
Company Name: CAREFUSION 2200, INC

Primary DI Number: 70885403135943
Issuing Agency: GS1
Commercial Distribution End Date: May 22, 2018
Device Count: 10
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: ENDOLAP 10.5MM OUTER SEAL CAP OUTER SEAL PACK 10 PER PK (X 10)

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?
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974382	000

Device Exempt from Premarket Submission: No 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: 418dc448-767d-4f55-b5d3-3302002273ba
Public Version Date: February 19, 2019
Public Version Number: 4
DI Record Publish Date: September 21, 2016