AccessGUDID - DEVICE: nxt™ Bipolar Forceps (04251388960264)

GUDID

Device Identifier (DI) Information

Brand Name: nxt™ Bipolar Forceps
Version or Model: Low Profile Ultra Non-Stick Microbipolar Forceps
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BIP-ATMI-06-IR
Company Name: adeor Medical AG

Primary DI Number: 04251388960264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341188943 *Terms of Use

Device Description: No description.

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?
56529	HLA class I antibody screening IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used in screening for one or multiple antibodies to HLA class I antigens in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191847	000

Device Exempt from Premarket Submission: No 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: 7bdae991-1353-4b4e-b5b3-3a25b2723189
Public Version Date: October 07, 2024
Public Version Number: 3
DI Record Publish Date: February 10, 2023