AccessGUDID - DEVICE: Symmetry Paparella (00887482114186)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Paparella
Version or Model: 61-0434
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61-0434
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00887482114186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Symmetry® Knife, "Whirly Bird" Paparella, Left

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?
35143	Sternum knife	A heavy-duty, hand-held manual surgical instrument designed for cutting into the sternum (the breastbone). It typically has a T-shaped handle to allow the application of pressure to the blade which descends from the handle in a thick shaft terminating in various contours. It is typically made of high-grade stainless steel; its handle may be made of a synthetic polymer (e.g., Tufnol). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMF	Knife, 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: 5ef65560-303d-472a-bdf8-c780a89be948
Public Version Date: October 29, 2025
Public Version Number: 4
DI Record Publish Date: August 12, 2024