FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569621261
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC306
Catalog number
ANC306
Published
2026-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569621261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569621261037005696212613700569621261

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
Device count
1
DM exempt
false
Premarket exempt
true
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
03700569626181NACT2.8L60CT2.8L602024-11-14
03700569626198NACT2.8L60-STCT2.8L60-ST2024-11-14
03700569627553NACT3.5L38DCT3.5L38D2024-11-14
03700569628154NACT3.5L10D-STCT3.5L10D-ST2024-11-14
03700569628178NACT3.5L12D-STCT3.5L12D-ST2024-11-14
03700569628192NACT3.5L14D-STCT3.5L14D-ST2024-11-14
03700569628215NACT3.5L16D-STCT3.5L16D-ST2024-11-14
03700569628239NACT3.5L18D-STCT3.5L18D-ST2024-11-14
03700569628291NACT3.5L24D-STCT3.5L24D-ST2024-11-14
03700569628314NACT3.5L26D-STCT3.5L26D-ST2024-11-14
03700569644536NACT3.5L10DCT3.5L10D2024-11-14
03700569644543NACT3.5L12DCT3.5L12D2024-11-14
03700569644550NACT3.5L14DCT3.5L14D2024-11-14
03700569644567NACT3.5L16DCT3.5L16D2024-11-14
03700569644574NACT3.5L18DCT3.5L18D2024-11-14
03700569644604NACT3.5L24DCT3.5L24D2024-11-14
03700569647100NACT4.5L30D2024-11-14
03700569647117NACT4.5L30D-STCT4.5L30D-ST2024-11-14
03700569647124NACT4.5L35DCT4.5L35D2024-11-14
03700569647131NACT4.5L35D-STCT4.5L35D-ST2024-11-14

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Primary DI, Brand, Company table
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00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
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