AccessGUDID - DEVICE: SUSI (04038653415281)

GUDID

Device Identifier (DI) Information

Brand Name: SUSI
Version or Model: BH110SU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BH110SU
Company Name: Aesculap AG

Primary DI Number: 04038653415281
Issuing Agency: GS1
Commercial Distribution End Date: October 26, 2021
Device Count: 20
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: HALSTED (MOSQUITO) SUSI Hemostatic Forceps, straight, 5", (125 mm), sterile, disposable, pack of 20 pcs, single packed

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?
61478	Surgical soft-tissue manipulation forceps, scissors-like, single-use	A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	FORCEPS

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
No Device Sizes

Device Record Status

Public Device Record Key: 64b58f93-cc09-4c4d-9080-b0a8e14538a6
Public Version Date: January 19, 2022
Public Version Number: 2
DI Record Publish Date: April 23, 2020