AccessGUDID - DEVICE: Pilling (10190776026612)

GUDID

Device Identifier (DI) Information

Brand Name: Pilling
Version or Model: 728146
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Avalign Technologies, Inc.

Primary DI Number: 10190776026612
Issuing Agency: GS1
Commercial Distribution End Date: November 21, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 792528510 *Terms of Use

Device Description: S-Retractor Set of 2

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?
45182	Self-retaining surgical retractor, reusable	A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
Width: 10 Millimeter
Length: 7.5 Inch

Device Record Status

Public Device Record Key: 28d9623a-f6af-4bd9-9485-5ab240b5f366
Public Version Date: November 22, 2023
Public Version Number: 4
DI Record Publish Date: March 23, 2017