AccessGUDID - DEVICE: Symmetry House (00887482114025)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry House
Version or Model: 61-0395
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61-0395
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00887482114025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Symmetry® Knife, House Tympanoplasty, 7.0mm Curved Blade, 6 1/2 in

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?
38102	Tympanotomy knife, reusable	A hand-held manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTG	Knife, Ent

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
Width: 7 Millimeter
Length: 6.5 Inch

Device Record Status

Public Device Record Key: 93c2b5e7-09d4-4556-a082-9f2b1075b188
Public Version Date: October 29, 2025
Public Version Number: 4
DI Record Publish Date: September 28, 2022