FDA.reportPublic FDA data

Symmetry Ultra®

Primary DI
00887482069240
Brand
Symmetry Ultra®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
32-132
Catalog number
32-132
Device description
Ultra Instruments® Wire Twister, Tungsten Carbide, 8 1/4 in, 209 mm
Published
2022-09-15
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
HXSTwister, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXSTwister, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482069240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482069240008874820692408874820692400887482069240

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting pliersA heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.25Inch

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
09348811105868INKAThe Trustee for KAISER FAMILY TRUSTHXS2026-06-02
09348811166029INKAThe Trustee for KAISER FAMILY TRUSTHXS2026-05-29
04052536085330neon3Ulrich GmbH & Co. KGHXS2026-05-28
04052536085361neon3Ulrich GmbH & Co. KGHXS2026-05-28
B8034803200ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803220ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803240ORTHOMEDORTHO-MED, INC.HXS2026-04-16
00888867500730Arthrex®ARTHREX, INC.HXS2026-03-13
00888867500747Arthrex®ARTHREX, INC.HXS2026-03-13
09348811105875INKAThe Trustee for KAISER FAMILY TRUSTHXS2025-11-26
04052536081097uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536081103uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536010585uCentumUlrich GmbH & Co. KGHXS2025-07-24
00190776394073MillenniumAvalign Technologies, Inc.HXS2025-05-06
00192896121379Wire TwisterSONTEC INSTRUMENTS, INC.HXS2025-04-11
00190776387372MillenniumAvalign Technologies, Inc.HXS2024-09-09
04049197086950RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXS2024-06-25
00192896116887Axel Wire Twister/CutterSONTEC INSTRUMENTS, INC.HXS2024-03-08
00888515056404BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204638BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204645BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204652BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204669BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
10840199532510Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
00840199532513Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
G586N2567460Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N8716610Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N98716620Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
00192896115828Wire TwisterSONTEC INSTRUMENTS, INC.HXS2023-11-16