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Peak Medical

FDA UDI

Class I (US FDA UDI)

by PEAK MEDICAL Distribution Inc

Identity

Trade Name
PEAK MEDICAL FDA UDI
Generic Name
Suture knot-tying device FDA UDI
Device Name
5mm, 37.5cm Working Length, Closed, Angled Tear Drop Shaped Tip, Knot Pusher, CM Markings, 3mm Oval Suture hole, "M" 6 sided Handle - Reusable - Stainless Steel. FDA UDI
Model / Reference
335210-531 FDA UDI
Description
5mm, 37.5cm Working Length, Closed, Angled Tear Drop Shaped Tip, Knot Pusher, CM Markings, 3mm Oval Suture hole, "M" 6 sided Handle - Reusable - Stainless Steel. FDA UDI

Identifiers

Primary DI / UDI-DI
G4533352105310 FDA UDI
FDA Product Code
HCF FDA UDI
GMDN Term
Suture knot-tying device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Suture knot-tying device

Peak Medical by PEAK MEDICAL Distribution Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture knot-tying device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PEAK MEDICAL Distribution Inc

Sources (1)

  • FDA UDI b58b6931-8c33-42e0-a9d4-7ed234f2a3e3 33 fields · synced Jun 1, 2026