FDA.reportPublic FDA data

HUNTER

Primary DI
00840420128959
Brand
HUNTER
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
TR400000
Catalog number
TR400000
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXRSPATULA, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853436000H-H HUNTER PASSIVE TENDON IMPLANTHolter-Hausner Intl.1985-10-16HXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420128959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420128959008404201289598404201289590840420128959

GMDN Terms#

Term, Definition table
TermDefinition
Tendon sheath regeneration implantA device intended to be implanted to temporarily aid growth of a new tendon sheath for tendon reconstruction. It is made of synthetic polymer (e.g., a silicone elastomer or polyester-reinforced silicone elastomer) and/or metal materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24.5Centimeter
Width4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797080392PRO-DENSE LoVisc87SRLV0587SRLV052023-11-21
00889797080415PRO-DENSE LoVisc87SRLV1087SRLV102023-11-21
00889797103589PRO-DENSE LoVisc87SRLV2087SRLV202023-11-21
00889797109796PRO-DENSE LoVisc1420LVGA1420LVGA2023-11-21
00889797076005MINI IGNITE 2.0876P0020876P00202022-08-23
00889797076012MINI IGNITE 2.0876P0040876P00402022-08-23
00889797076036IGNITE 2.0876P0200876P02002022-08-23
00889797076029IGNITE™ 2.0876P0080876P00802022-02-24
00889797072700PRO-DENSE™87SR015087SR01502020-09-08
00889797072717PRO-DENSE™87SR040087SR04002020-09-08
00889797072724PRO-DENSE™87SRCDK087SRCDK02020-09-08
00889797072748PRO-DENSE™87SR002087SR00202020-09-08
00889797072755PRO-DENSE™87SR005087SR00502020-09-08
00889797072762PRO-DENSE™87SR010087SR01002020-09-08
00889797073301PRO-DENSE™87SR007087SR00702020-09-08
00889797073318PRO-DENSE™87SR012087SR01202020-09-08
00840420133434OSTEOSET84000211840002112015-10-15
00840420133465OSTEOSET84000305840003052015-10-15
00840420133472OSTEOSET84000310840003102015-10-15
00840420133489OSTEOSET84000311840003112015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811146700INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
09348811146717INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
04059223157875REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223157899REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223157943REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223160837REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223160844REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223166273REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223166280REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341216REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341230REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341278REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341223REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341247REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341254REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341261REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
D105SKU1312100SurgiMac Surgimac LLCHXR2024-04-22
00842517117280Karl SchumacherKarl Schumacher Dental, LLCHXR2024-03-15
00850047707260GillThe Radebaugh-Fetzer CompanyHXR2023-06-01
04026575341368LINK Instruments - Chisel, bone curette, raspatory, rongeurWALDEMAR LINK GmbH & Co. KGHXR2022-12-20
08800017284620LOSPA IS Spinal SystemCorentec Co., LtdHXR2022-10-20
00681490912235Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00681490912242Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00840319718230Hayden MedicalHayden Medical, Inc.HXR2022-08-03
00840319701492Hayden MedicalHayden Medical, Inc.HXR2022-07-22
00840319701508Hayden MedicalHayden Medical, Inc.HXR2022-07-22
04251436928604KOHDENTKohler Medizintechnik GmbHHXR2021-09-22
04251436915178KOHDENTKohler Medizintechnik GmbHHXR2021-08-30
04251436921902KOHDENTKohler Medizintechnik GmbHHXR2021-08-30
04251436925115KOHDENTKohler Medizintechnik GmbHHXR2021-08-30