FDA.reportPublic FDA data

NA

Primary DI
03700569608446
Brand
NA
Company
NEWCLIP TECHNICS
Model
HTSIS1
Catalog number
HTSIS1
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142502000ALIANS ULNA LOCKING PLATING SYSTEMNewclip Technics2014-12-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569608446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569608446037005696084463700569608446

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569653873NACT2.8L10DCT2.8L10D2026-11-05
03700569658274NAH1.25QT3.5L44DH1.25QT3.5L44D2026-11-05
03700569658281NAH1.25QT3.5L44D-STH1.25QT3.5L44D-ST2026-11-05
03700569667931NAH1.25QT3.5L14DH1.25QT3.5L14D2026-11-05
03700569667948NAH1.25QT3.5L14D-STH1.25QT3.5L14D-ST2026-11-05
03700569667955NAH1.25QT3.5L16DH1.25QT3.5L16D2026-11-05
03700569667962NAH1.25QT3.5L16D-STH1.25QT3.5L16D-ST2026-11-05
03700569667979NAH1.25QT3.5L18DH1.25QT3.5L18D2026-11-05
03700569667986NAH1.25QT3.5L18D-STH1.25QT3.5L18D-ST2026-11-05
03700569667993NAH1.25QT3.5L20DH1.25QT3.5L20D2026-11-05
03700569668006NAH1.25QT3.5L20D-STH1.25QT3.5L20D-ST2026-11-05
03700569668013NAH1.25QT3.5L22DH1.25QT3.5L22D2026-11-05
03700569668020NAH1.25QT3.5L22D-STH1.25QT3.5L22D-ST2026-11-05
03700569668037NAH1.25QT3.5L24DH1.25QT3.5L24D2026-11-05
03700569668044NAH1.25QT3.5L24D-STH1.25QT3.5L24D-ST2026-11-05
03700569668051NAH1.25QT3.5L26DH1.25QT3.5L26D2026-11-05
03700569668068NAH1.25QT3.5L26D-STH1.25QT3.5L26D-ST2026-11-05
03700569668075NAH1.25QT3.5L28DH1.25QT3.5L28D2026-11-05
03700569668082NAH1.25QT3.5L28D-STH1.25QT3.5L28D-ST2026-11-05
03700569668099NAH1.25QT3.5L30DH1.25QT3.5L30D2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLEAPSynthes GmbHHRS2024-02-23
00810112592252TriLEAPSynthes GmbHHRS2024-02-23
00810112592429TriLEAPSynthes GmbHHRS2024-02-23
00810112592450TriLEAPSynthes GmbHHRS2024-02-23
00810112592467TriLEAPSynthes GmbHHRS2024-02-23
00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
00810112593013TriLEAPSynthes GmbHHRS2024-02-22
00810112593020TriLEAPSynthes GmbHHRS2024-02-22
00810112593037TriLEAPSynthes GmbHHRS2024-02-22
00810112593044TriLEAPSynthes GmbHHRS2024-02-22
00810112593051TriLEAPSynthes GmbHHRS2024-02-22
00810112593068TriLEAPSynthes GmbHHRS2024-02-22
00810112593075TriLEAPSynthes GmbHHRS2024-02-22
00810112593082TriLEAPSynthes GmbHHRS2024-02-22
00810112593099TriLEAPSynthes GmbHHRS2024-02-22
00810112593105TriLEAPSynthes GmbHHRS2024-02-22
00810112593112TriLEAPSynthes GmbHHRS2024-02-22
00810112593129TriLEAPSynthes GmbHHRS2024-02-22
00810112593136TriLEAPSynthes GmbHHRS2024-02-22
00810112593143TriLEAPSynthes GmbHHRS2024-02-22
00810112593150TriLEAPSynthes GmbHHRS2024-02-22
00810112593167TriLEAPSynthes GmbHHRS2024-02-22
00810112593174TriLEAPSynthes GmbHHRS2024-02-22
00810112593181TriLEAPSynthes GmbHHRS2024-02-22