Proximate

FDA UDI

Class I (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

Identity

Trade Name: Proximate FDA UDI
Generic Name: Skin stapler/staple, non-bioabsorbable FDA UDI
Device Name: Proximate skin Staplers (35 Regular) Contains 35 Stainless Steel Staples (Fixed Head) FDA UDI
Model / Reference: PXR35 FDA UDI
Description: Proximate skin Staplers (35 Regular) Contains 35 Stainless Steel Staples (Fixed Head) FDA UDI

Identifiers

Catalog Number: PXR35 FDA UDI
Primary DI / UDI-DI: 10705036002666 FDA UDI
FDA Product Code: GDT FDA UDI
GMDN Term: Skin stapler/staple, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Skin stapler/staple, non-bioabsorbable

Proximate by Ethicon Endo-Surgery, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ethicon Endo-Surgery, Inc.

Sources (1)

FDA UDI 2587f04b-67fb-41ee-9671-176196e62add 35 fields · synced May 30, 2026