FDA.reportPublic FDA data

NA

Primary DI
03700569604363
Brand
NA
Company
NEWCLIP TECHNICS
Model
QOT3.5L24
Catalog number
QOT3.5L24
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142502000
K262649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142502000ALIANS ULNA LOCKING PLATING SYSTEMNewclip Technics2014-12-23HRS
K262649000Alians ForearmNewclip Technics2026-09-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569604363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569604363037005696043633700569604363

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
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
true
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
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
03700569653873NANEWCLIP TECHNICSHWC2026-11-05
03700569658274NANEWCLIP TECHNICSHWC2026-11-05
03700569658281NANEWCLIP TECHNICSHWC2026-11-05
03700569667931NANEWCLIP TECHNICSHWC2026-11-05
03700569667948NANEWCLIP TECHNICSHWC2026-11-05
03700569667955NANEWCLIP TECHNICSHWC2026-11-05
03700569667962NANEWCLIP TECHNICSHWC2026-11-05
03700569667979NANEWCLIP TECHNICSHWC2026-11-05
03700569667986NANEWCLIP TECHNICSHWC2026-11-05
03700569667993NANEWCLIP TECHNICSHWC2026-11-05
03700569668006NANEWCLIP TECHNICSHWC2026-11-05
03700569668013NANEWCLIP TECHNICSHWC2026-11-05
03700569668020NANEWCLIP TECHNICSHWC2026-11-05
03700569668037NANEWCLIP TECHNICSHWC2026-11-05
03700569668044NANEWCLIP TECHNICSHWC2026-11-05
03700569668051NANEWCLIP TECHNICSHWC2026-11-05
03700569668068NANEWCLIP TECHNICSHWC2026-11-05
03700569668075NANEWCLIP TECHNICSHWC2026-11-05
03700569668082NANEWCLIP TECHNICSHWC2026-11-05
03700569668099NANEWCLIP TECHNICSHWC2026-11-05
03700569668105NANEWCLIP TECHNICSHWC2026-11-05
03700569668112NANEWCLIP TECHNICSHWC2026-11-05
03700569668129NANEWCLIP TECHNICSHWC2026-11-05
03700569668136NANEWCLIP TECHNICSHWC2026-11-05
03700569668143NANEWCLIP TECHNICSHWC2026-11-05
03700569668150NANEWCLIP TECHNICSHWC2026-11-05
03700569668167NANEWCLIP TECHNICSHWC2026-11-05
03700569668174NANEWCLIP TECHNICSHWC2026-11-05
03700569668181NANEWCLIP TECHNICSHWC2026-11-05
03700569668198NANEWCLIP TECHNICSHWC2026-11-05