FDA.reportPublic FDA data

NA

Primary DI
00840085270758
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
NZA015001
Catalog number
NZA015001
Device description
TULIP UNLOCKER, HIGH TOP
Published
2024-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWLPeripheral Catheter Insertion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085270758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085270758008400852707588400852707580840085270758

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047PARKER@ASTURAMEDICAL.COM

Regulatory Flags#

DUNS number
073029645
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840085271861NAAZA083000AZA0830002025-02-26
00840085271878NAAZA084000AZA0840002025-02-26
00840085271885NAAZA084001AZA0840012025-02-26
00840085271892NAAZA085000AZA0850002025-02-26
00840085271908NAAZA085001AZA0850012025-02-26
00840085271915NAAZA086000AZA0860002025-02-26
00840085271922NAAZA088035AZA0880352025-02-26
00840085271939NAAZA088040AZA0880402025-02-26
00840085271946NAAZA088045AZA0880452025-02-26
00840085271953NAAZA088050AZA0880502025-02-26
00840085271960NAAZA088055AZA0880552025-02-26
00840085271977NAAZA088060AZA0880602025-02-26
00840085271984NAAZA088065AZA0880652025-02-26
00840085271991NAAZA088070AZA0880702025-02-26
00840085272004NAAZA088075AZA0880752025-02-26
00840085272011NAAZA088080AZA0880802025-02-26
00840085272028NAAZA088085AZA0880852025-02-26
00840085272035NAAZA088090AZA0880902025-02-26
00840085272042NAAZA088095AZA0880952025-02-26
00840085272066NAAZA091000AZA0910002025-02-26

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Primary DI, Brand, Company table
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30849884007320VYGONVygon CorporationOWL2026-02-11
50198956291667CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
50198956188127CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
50198956266665CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
50198956263558CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
50198956257113CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
50198956184457CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
50198956165432CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
20809160486389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OWL2025-07-22
50197106694808CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10661392007663LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392007830LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
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10661392027555LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027678LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392028309LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
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10661392037981LSL HEALTHCARELSL Industries, LLCOWL2025-05-16