FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482054772
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
11-2095
Catalog number
11-2095
Device description
Symmetry® Breaker, Wolfe-Boehler Cast, 10 in
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGGInstrument, Cast Application/Removal, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482054772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482054772008874820547728874820547720887482054772

GMDN Terms#

Term, Definition table
TermDefinition
Cast breakerA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887482196533Symmetry Barraquer60-1906-SYM60-1906-SYM2025-07-24
00887482196540Symmetry Castroviejo60-1910-SYM60-1910-SYM2025-07-24
00887482012307Symmetry Tyrell 38-652538-65252022-09-16
00887482006559Symmetry Surgical32-348532-34852024-09-05
00887482006566Symmetry Surgical32-348532-34852024-09-05
00887482196793Symmetry Surgical90-1042R90-1042R2024-09-05
00887482030578Symmetry Hardy80-133080-13302024-09-05
00887482030585Symmetry Hardy80-133180-13312024-09-05
00887482030592Symmetry Hardy80-133280-13322024-09-05
00887482030608Symmetry Hardy80-133380-13332024-09-05
00887482030615Symmetry Hardy80-133480-13342024-09-05
00887482030622Symmetry Hardy80-133580-13352024-09-05
00887482030707Symmetry Hardy80-134580-13452024-09-05
00887482030714Symmetry Hardy80-134680-13462024-09-05
00887482030721Symmetry Hardy80-134780-13472024-09-05
00887482030738Symmetry Hardy80-134880-13482024-09-05
00887482031124Symmetry Verity™80-153680-15362024-09-05
00887482031506Symmetry Rhoton®80-169280-16922024-09-05
00887482031513Symmetry Rhoton®80-169380-16932024-09-05
00887482116203Symmetry Paparella61-377561-37752024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613087906MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-08-01
04049047005001GimmiGimmi GmbHLGG2025-04-02
00194613008345MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-03-21
00887482044421Symmetry Surgical®SYMMETRY SURGICAL INC.LGG2024-08-15
00887482037287Symmetry Surgical®SYMMETRY SURGICAL INC.LGG2024-08-12
00840183517687BR Surgical, LLCBR Surgical, LLCLGG2024-03-14
00840183505738BR Surgical, LLCBR Surgical, LLCLGG2024-03-13
00888515326071BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
00888515326088BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
44026704722301KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
00840183521196BR Surgical, LLCBR Surgical, LLCLGG2024-02-06
G586N5166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166370Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166480Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95171160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95174160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95177160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95182410Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95192310Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
00842331194016Novo Surgical Inc. NOVO SURGICAL, INC.LGG2023-12-07
44026704722295KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
00190776283667AvalignAvalign Technologies, Inc.LGG2023-09-28
00840183502652BR Surgical, LLCBR Surgical, LLCLGG2023-05-26
00842962122174HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29
00842962122181HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29
00842962122198HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29
00842962122204HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29
00842962122211HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29
00840319745861Hayden MedicalHayden Medical, Inc.LGG2023-03-14