AccessGUDID - DEVICE: Pilling (00190776025038)

GUDID

Device Identifier (DI) Information

Brand Name: Pilling
Version or Model: P30879
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Avalign Technologies, Inc.

Primary DI Number: 00190776025038
Issuing Agency: GS1
Commercial Distribution End Date: November 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 792528510 *Terms of Use

Device Description: Tenaculum Forceps with Ratchet, Flush

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?
13998	Uterine tenaculum	A hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.	Active	false

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
Length: 45 Centimeter
Width: 5 Millimeter

Device Record Status

Public Device Record Key: d2078b9b-6235-43ef-91b6-a95cc82e220d
Public Version Date: November 22, 2023
Public Version Number: 4
DI Record Publish Date: March 23, 2017