AccessGUDID - DEVICE: V. Mueller (10885403014956)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: BE2105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BE2105
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403014956
Issuing Agency: GS1
Commercial Distribution End Date: January 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: KRAUSE THROUGH-CUTTING FORCEPS TIP STRAIGHT, 6X4MM OVAL CUP JAWS OVERALL LENGTH 3.9 CM

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?
62466	Surgical soft-tissue manipulation forceps, tweezers-like, reusable	A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAE	FORCEPS, ENT

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: 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: 008e476f-81c3-46c5-9074-e1449b4b7015
Public Version Date: December 11, 2019
Public Version Number: 4
DI Record Publish Date: August 02, 2018