AccessGUDID - DEVICE: Symmetry Boucheron (00887482145845)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Boucheron
Version or Model: 61-0905
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61-0905
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00887482145845
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Symmetry® Speculum, Boucheron, Chrome Plated, Round, Large, 5.5 mm To 9.0 mm, (4/st)

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?
33393	Gelfoam punch	A manual instrument designed to punch circles of various sizes from a piece of Gelfoam (a sterile compressed gelatin sponge having haemostatic properties which usually absorbs completely within four to six weeks) typically used to help construct ossicular replacements during middle ear surgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPY	Speculum, 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
Circumference: 5.5 Millimeter
Circumference: 9 Millimeter

Device Record Status

Public Device Record Key: d856cb8d-948d-4d35-84c4-cea20d748153
Public Version Date: October 29, 2025
Public Version Number: 5
DI Record Publish Date: September 29, 2022