FDA.report

PERFORMANCE HEALTH

Primary DI
00840216112117
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
A37132
Device description
90° Wire Bender
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXWBender

Product Code Classifications

CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216112117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216112117008402161121178402161121170840216112117

GMDN Terms

TermDefinition
ENT wire bending dieA device designed for external conforming (i.e., bending) of wires during ear/nose/throat (ENT), otorhinolaryngology procedures. The device consists of a metallic solid base and appropriate attachments on its surface that permit bending of wires in appropriate angles (e.g., 90?, 45?); it typically includes a millimetric scale to improve the precision of the procedure. It is used to conform wires on a separate table or bench as they are needed, typically while performing endaural (ear) surgery. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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00840216128293ASP GLOBALEGT3082025-06-17
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00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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