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Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Razor blade breaker/holder FDA UDI
Device Name
Stainless steel breakable blades, non-sterile, box of 50 FDA UDI
Model / Reference
Stainless steel breakable blades FDA UDI
Description
Stainless steel breakable blades, non-sterile, box of 50 FDA UDI

Identifiers

Catalog Number
1017E FDA UDI
Primary DI / UDI-DI
00190660001070 FDA UDI
FDA Product Code
HNN FDA UDI
GMDN Term
Razor blade breaker/holder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Razor blade breaker/holder

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Razor blade breaker/holder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI b03540d7-db0f-46f2-98e1-3c2b13fdeeea 35 fields · synced Jun 1, 2026