AccessGUDID - DEVICE: Symmetry Wolfe-Boehler (00887482054772)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Wolfe-Boehler
Version or Model: 11-2095
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-2095
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482054772
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Symmetry® Breaker, Wolfe-Boehler Cast, 10 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?
46313	Cast breaker	A manual surgical instrument with strong, curved blades used to grasp and break apart hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with curved serrated (serrated on the inside to provide grip) blades. These blades are prised between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create a grip on the plaster that can then be broken off in pieces. It is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGG	Instrument, Cast Application/Removal, Manual

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: 99a98b21-1155-4a21-8035-a3ddc59e59c6
Public Version Date: March 06, 2025
Public Version Number: 3
DI Record Publish Date: August 15, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-364-7004
Email: customerservice@symmetrysurgical.com

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