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Solustaple®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name
SOLUSTAPLE® FDA UDI
Generic Name
Orthopaedic bone staple driver FDA UDI
Device Name
The staple holder and impactor is used to handle and insert the SOLUS 26° staples. FDA UDI
Model / Reference
119403ND FDA UDI
Description
The staple holder and impactor is used to handle and insert the SOLUS 26° staples. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780045953 FDA UDI
FDA Product Code
HWA FDA UDI
GMDN Term
Orthopaedic bone staple driver FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone staple driver

Solustaple® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple driver.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Newdeal Sas

Sources (1)

  • FDA UDI 67ae96d3-1cf2-4000-b3da-5302da6486b0 35 fields · synced Jun 6, 2026