FDA.reportPublic FDA data

Symmetry Wolff-Boehler

Primary DI
00887482044421
Brand
Symmetry Wolff-Boehler
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
40-8118
Catalog number
40-8118
Device description
Symmetry® Cast Breaker, Wolf-Boehler, 7 in
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00887482044421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482044421008874820444218874820444210887482044421

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

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
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421526MillenniumAvalign Technologies, Inc.LGG2026-05-05
00810058670533Professional Surgical Instruments Co., Inc. Professional Surgical Instruments Co., Inc.LGG2026-02-12
00194613087906MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-08-01
04049047005001GimmiGimmi GmbHLGG2025-04-02
00194613008345MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-03-21
00840306823039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LGG2025-01-17
00887482054772Symmetry Wolfe-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482037287Symmetry WaltonASPEN SURGICAL PRODUCTS, 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
14026704722300KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
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
14026704722294KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
44026704722295KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
00190776283667AvalignAvalign Technologies, Inc.LGG2023-09-28
00840183502652BR Surgical, LLCBR Surgical, LLCLGG2023-05-26
00842962122174HNM MEDICALHNM STAINLESS, LLC.LGG2023-03-29