FDA.reportPublic FDA data

Symmetry Wolff-Boehler

Primary DI
00887482073049
Brand
Symmetry Wolff-Boehler
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
40-8124
Catalog number
40-8124
Device description
Symmetry® Cast Breaker, Wolf-Boehler, 10 5/8 in
Published
2022-09-16
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
DWHBlade, Saw, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWHBlade, Saw, Surgical, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482073049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482073049008874820730498874820730490887482073049

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10.625Inch

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
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475564TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475571TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475588TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475595TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
08809260475601TRAUSSaeshin Precision Co., Ltd.DWH2026-04-09
00887482085493Symmetry JacobsonASPEN SURGICAL PRODUCTS, INC.DWH2022-09-22
00190776162993MillenniumAvalign Technologies, Inc.DWH2021-11-01
00190776163006MillenniumAvalign Technologies, Inc.DWH2021-11-01
00190776163013MillenniumAvalign Technologies, Inc.DWH2021-11-01
00190776163020MillenniumAvalign Technologies, Inc.DWH2021-11-01
17630055509472Short Microsaw Blade 22x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509588Short Microsaw Blade 27x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509595Short Microsaw Blade 32x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509601Short Microsaw Blade 22x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509618Short Microsaw Blade 27x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509625Short Microsaw Blade 32x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509632Long Microsaw Blade 22x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509649Long Microsaw Blade 27x0.4mmBien-Air Surgery SADWH2021-02-22
17630055509656Long Microsaw Blade 32x0.4mm Bien-Air Surgery SADWH2021-02-22
17630055509663Long Microsaw Blade 22x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509670Long Microsaw Blade 27x0.6mmBien-Air Surgery SADWH2021-02-22
17630055509687Long Microsaw Blade 32x0.6mmBien-Air Surgery SADWH2021-02-22
04046963091521AESCULAPAesculap AGDWH2020-05-08
04046963413675AESCULAPAesculap AGDWH2020-05-08
04046963839345AESCULAPAesculap AGDWH2020-05-08
07613153097709NASTRYKER CORPORATIONDWH2018-09-23
07613154501144Stryker Performance SeriesSTRYKER CORPORATIONDWH2018-09-23
04546540897923NASTRYKER CORPORATIONDWH2018-09-23
04546540042101NASTRYKER CORPORATIONDWH2018-09-23
04546540169594NASTRYKER CORPORATIONDWH2018-09-23