AccessGUDID - DEVICE: AESCULAP (04046963945374)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: PO234R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PO234R
Company Name: Aesculap AG

Primary DI Number: 04046963945374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: ADTEC MONOPOLAR Grasping Forceps, complete instrument, straight, (420 mm), diam. 5 mm, serrated, jaw with longitudinal groove, single action, consisting of PM981R, PO787R, PO959R, reusable

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Utility forceps, reusable	A hand-held manual surgical instrument used for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have grasping blades that are elongated or shaped as large oval or triangular rings. The blades are usually serrated to enhance grip on the objects being picked up. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Utility forceps, reusable

A hand-held manual surgical instrument used for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have grasping blades that are elongated or shaped as large oval or triangular rings. The blades are usually serrated to enhance grip on the objects being picked up. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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: 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
Device Size Text, specify: Length : 420.000 MM
Device Size Text, specify: Diameter (mm) : 5.000 MM

Device Record Status

Public Device Record Key: 6671008f-a113-4aed-adc6-9ff84f077c5f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016