AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197306652)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 410-216-009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 410-216-009
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197306652
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: PLESTER Antrum Hook 160mm, 90° angled, cylindrical shape

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":	Yes
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?
42595	Soft-tissue surgical hook, reusable	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

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: e322d145-da58-4ae0-8e89-cf37d5e22ecf
Public Version Date: July 08, 2024
Public Version Number: 1
DI Record Publish Date: June 28, 2024