FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660111977
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Wire twister
Catalog number
45-510
Device description
Wire twister, 6 1/2'', grooved jaws, 1.0mm max capacity, ring handle
Published
2021-01-04
Public version status
New
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
00190660111977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660111977001906601119771906601119770190660111977

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting forcepsA surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190776301842MillenniumAvalign Technologies, Inc.HXS2023-11-15
00190776053406AvalignAvalign Technologies, Inc.HXS2023-09-28
00190776331559MILLENNIUMAvalign Technologies, Inc.HXS2023-09-28
00190776331566MILLENNIUMAvalign Technologies, Inc.HXS2023-09-28